A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

Last updated: May 6, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Pressure Ulcers

Bronchiectasis

Treatment

AZD0292

Placebo

Clinical Study ID

NCT07088926
D7700C00003
  • Ages > 12
  • All Genders

Study Summary

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be ≥ 12 years of age at the time of signing the informedconsent/assent

  2. Weight ≥ 35 kg

  3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormalbronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 yearsis acceptable. If not available, a CT scan should be conducted at screening toconfirm eligibility.

  4. Participants who are receiving appropriate standard of care therapy per localguidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severeexacerbation in the preceding 12 months requiring antibiotics

  5. Participants who are clinically stable and free from an exacerbation ofbronchiectasis for 4 weeks prior to randomization

  6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value atscreening.

  7. Presence of positive (PCR or culture) PsA in an airway sample at least once in thelast 24 months prior to screening

  8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization.Participants who have previously received PsA eradication therapy, as determinedappropriate by their treating provider, but remain colonized with PsA are eligiblefor the study.

  9. Capable of giving signed informed consent/assent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol

Exclusion

Exclusion Criteria:

  1. Primary lung diagnosis other than bronchiectasis

  2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treatedor requiring treatment. Participants currently receiving treatment for active TB ornontuberculous mycobacteria may be considered after completion of an appropriatecourse of therapy

  3. Evidence of an active allergic bronchopulmonary aspergillosis being treated orrequiring treatment

  4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief ofbreathlessness after exercise is allowed

  5. Malignancy, current or within the previous 5 years, except for stable prostatecancer, adequately treated non-invasive basal cell and squamous cell carcinoma ofthe skin and cervical carcinoma in situ treated with apparent success more than oneyear prior to enrolment

  6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of < 200 cells/mm3)

  7. History of severe adverse reaction associated with a mAb, and/or history of severeallergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenalineor hospitalization), and/or history of immune complex disease (Type IIIhypersensitivity reactions) to monoclonal antibody administration

  8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors,which are newly initiated within the 3 months prior to screening

  9. Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent)newly initiated within the last 3 months

  10. Receipt of investigational products indicated for the treatment or prevention ofbronchiectasis exacerbations or expected receipt during the study

  11. Participants with CF on CFTR modulator therapies which are newly initiated withinthe previous 3 months prior to screening

  12. Female participants who are pregnant, lactating, or WOCBP and not using a highlyeffective method of contraception or abstinence from at least 4 weeks prior to studyintervention administration and until at least 6 months after study interventionadministration

Study Design

Total Participants: 435
Treatment Group(s): 2
Primary Treatment: AZD0292
Phase: 2
Study Start date:
November 06, 2025
Estimated Completion Date:
June 14, 2028

Study Description

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older.

The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.

Connect with a study center

  • Research Site

    Ciudad de Buenos Aires, C1180AAX
    Argentina

    Active - Recruiting

  • Research Site

    Florida, B1602DQD
    Argentina

    Active - Recruiting

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    Florida 3433908, B1602DQD
    Argentina

    Site Not Available

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    Rosario, 2000
    Argentina

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    Rosario 3838583, 2000
    Argentina

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    San Miguel de Tucumán, 4000
    Argentina

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    San Miguel de Tucumán 3836873, 4000
    Argentina

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    Birtinya, 4575
    Australia

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    Macquarie University, 2109
    Australia

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    South Brisbane, 4101
    Australia

    Active - Recruiting

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    South Brisbane 2207259, 4101
    Australia

    Site Not Available

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    Gent, 9000
    Belgium

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    Ghent, 9000
    Belgium

    Active - Recruiting

  • Research Site

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Research Site

    Leuven 2792482, 3000
    Belgium

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  • Research Site

    Liege, 4000
    Belgium

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    Liège, 4000
    Belgium

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    Liège 2792413, 4000
    Belgium

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    Sint-Niklaas, 9100
    Belgium

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    Sint-Niklaas 2786578, 9100
    Belgium

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    Blumenau, 89030-101
    Brazil

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    Blumenau 3469968, 89030-101
    Brazil

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    Campinas, 13060-080
    Brazil

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    Campinas 3467865, 13060-080
    Brazil

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    Curitiba, 80030-110
    Brazil

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    Curitiba 3464975, 80230-130
    Brazil

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    Porto Alegre, 9061-000
    Brazil

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    Porto Alegre 3452925, 91350-200
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    Salvador, 40050-410
    Brazil

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    Salvador 3450554, 40050-410
    Brazil

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    São José dos Campos, 12230-001
    Brazil

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    São José dos Campos 3448636, 12230-001
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    São Paulo, 05403-000
    Brazil

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    São Paulo 3448439, 05403-000
    Brazil

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    Calgary, Alberta T2N4Z6
    Canada

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    Calgary 5913490, Alberta 5883102 T2N4Z6
    Canada

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    Vancouver, British Columbia V5Z 1M9
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    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
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    Ajax, Ontario L1S 2J5
    Canada

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    Stoney Creek, Ontario L8G 2V6
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    Ajax 5882873, Ontario 6093943 L1S 2J5
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    Stoney Creek 6157390, Ontario 6093943 L8G 2V6
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    Québec, Quebec G1V 4G5
    Canada

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    Saint-Charles-Borromée, Quebec J6E 2B4
    Canada

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    Trois-Rivières, Quebec G8T 7A1
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    Québec 6325494, Quebec 6115047 G1V 4G5
    Canada

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    Saint-Charles-Borromée 6137579, Quebec 6115047 J6E 2B4
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    Trois-Rivières 6169141, Quebec 6115047 G8T 7A1
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    Concepción, 4070196
    Chile

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    Concepción 3893894, 4070196
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    Santiago, 8380453
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    Santiago 3871336, 8380453
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    Talca, 3481349
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    Talca 3870294, 3481349
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    Viña del Mar, 2540364
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    Viña del Mar 3868121, 2540364
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    Aalborg, 9000
    Denmark

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    Aalborg 2624886, 9000
    Denmark

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    Aarhus N, 8200
    Denmark

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    Aarhus N 11746890, 8200
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    Hvidovre, 2650
    Denmark

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    Hvidovre 2619528, 2650
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    Odense C, 5000
    Denmark

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    Odense C 11746507, 5000
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    Roskilde, 4000
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    Roskilde 2614481, 4000
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    Brest, 29200
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    Brest 3030300, 29200
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    Créteil, 94010
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    Créteil 3022530, 94010
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    Marseille, 13915
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    Marseille 2995469, 13915
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    Montpellier, 34295
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    Montpellier 2992166, 34295
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    Paris, 75014
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    Paris 2988507, 75014
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    Frankfurt, 60596
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    Halle, 06108
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    Halle 2911522, 06108
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    Hanover, 30625
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    Hanover 2910831, 30625
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    Konstanz, 78464
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    Konstanz 2885679, 78464
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    München, 80336
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    München 2867711, 80336
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    München-Pasing, 81241
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    Athens, 15126
    Greece

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    Athens 264371, 17562
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    Ioannina, 45500
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    Ioannina 261779, 45500
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    Larissa, 41110
    Greece

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    Larissa 258576, 41110
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    Pátrai, 26500
    Greece

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    Pátrai 255683, 26500
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    Thessaloniki, 57010
    Greece

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    Thessaloniki 734077, 57010
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    Ashkelon, 7830604
    Israel

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    Ashkelon 295620, 7830604
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    Haifa, 34362
    Israel

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    Haifa 294801, 34362
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    Jerusalem, 00000
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    Jerusalem 281184, 00000
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    Ramat Gan, 52621
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    Ramat Gan 293788, 52621
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    Tel Aviv, 6423906
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    Tel Aviv 293397, 6423906
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    Milan, 20122
    Italy

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    Milan 6951411, 20122
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    Palermo, 90127
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    Palermo 2523920, 90127
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    Pavia, 27100
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    Pavia 3171366, 27100
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    Perugia, 06129
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    Perugia 3171180, 06129
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    Roma, 00163
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    Roma 8957247, 00163
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    Rozzano, 20089
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    Rozzano 3168837, 20089
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    Torrette, 60126
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    Torrette 8960841, 60126
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    Bunkyō City, 113-8655
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    Gifu, 500-8717
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    Hiratsuka-shi, 254-8502
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    Kamogawa-shi, 296-0041
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    Kiyose-shi, 204-8585
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    Kurashiki-shi, 710-8602
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    Miyazaki, 889-1692
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    Nagasaki, 852-8501
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    Ogi, 845-0032
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    Shinjuku-ku, 160-8582
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    Urayasu-shi, 279-0021
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    Bandar Puncak Alam, 42300
    Malaysia

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    Bandar Puncak Alam 11429145, 42300
    Malaysia

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    Kuala Lumpur, 59100
    Malaysia

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    Kuala Lumpur 1735161, 59100
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    Puncak Alam, 42300
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    Sibu, 96000
    Malaysia

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    Sibu 1735902, 96000
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    Amsterdam, 1081 HV
    Netherlands

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    Amsterdam 2759794, 1081 HV
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    Rotterdam, 3015 GD
    Netherlands

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    Rotterdam 2747891, 3015 GD
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    Zutphens, 7207 AE
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    Bellavista, CALLAO 2
    Peru

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    Bellavista 3699364, CALLAO 2
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    Callao, Bellavista
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    Lima, 15088
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    Lima 3936456, 15038
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    Iloilo City, 5000
    Philippines

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    Iloilo City 1711005, 5000
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    Manila, 1000
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    Manila 1701668, 1000
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    Quezon City, 1100
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    Quezon City 1692192, 1100
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    Tondo, 1012
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    Tondo 1681502, 1012
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    Anyang-si, 14068
    South Korea

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    Anyang-si 1846898, 14068
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    Cheongju-si, 28644
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    Cheongju-si 1845604, 28644
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    Daegu, 42415
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    Daegu 1835329, 42415
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    Seongnam-si 1897000, 13620
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    Seoul 1835848, 04763
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    Ulsan 1833747, 44033
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    Barcelona, 08003
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    Barcelona 3128760, 08036
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    Benalmádena, 29631
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    Benalmádena 2521139, 29631
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    Madrid, 28040
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    Madrid 3117735, 28040
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    Merida, 06800
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    Mérida, 06800
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    Mérida 2513917, 06800
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    Patraix 12023269, 46017
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    Valencia 2509954, 46009
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    Taoyuan, 333
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    Taoyuan District, 333
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    Taoyuan District 1667905, 333
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    Bang Kra So, 11000
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    Bangkok, 10400
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    Bangkok 1609350, 10400
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    Khon Kaen 1609776, 40002
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    Muang, 50200
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    Pathum Thani 1607983, 12120
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    Ankara 323786, 6340
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    Diyarbakır, 21280
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    Diyarbakır 316541, 21280
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    Istanbul, 34890
    Turkey (Türkiye)

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    Istanbul 745044, 34890
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    Mersin 304531, 33343
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    Zeytinburnu 737071, 34020
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    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester 2643123, M23 9LT
    United Kingdom

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Research Site

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Research Site

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Research Site

    Denver, Colorado 80206
    United States

    Site Not Available

  • Research Site

    Washington D.C., District of Columbia 20007
    United States

    Active - Recruiting

  • Research Site

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Research Site

    Miami Lakes, Florida 33014
    United States

    Suspended

  • Research Site

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Research Site

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Research Site

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Research Site

    Jacksonville 4160021, Florida 4155751 32209
    United States

    Site Not Available

  • Research Site

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Research Site

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • Research Site

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Site Not Available

  • Research Site

    Plantation 4168782, Florida 4155751 33324
    United States

    Site Not Available

  • Research Site

    Rincon, Georgia 31326
    United States

    Active - Recruiting

  • Research Site

    Rincon 4218882, Georgia 4197000 31326
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Research Site

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63130
    United States

    Active - Recruiting

  • Research Site

    St Louis 4407066, Missouri 4398678 63130
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Research Site

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Research Site

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Research Site

    Tulsa 4553433, Oklahoma 4544379 74133
    United States

    Site Not Available

  • Research Site

    DuBois, Pennsylvania 15801
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    DuBois 5187432, Pennsylvania 6254927 15801
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Research Site

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Research Site

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Research Site

    Rock Hill 4593142, South Carolina 4597040 29732
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78705
    United States

    Site Not Available

  • Research Site

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Research Site

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Research Site

    Mansfield 4709013, Texas 4736286 76063
    United States

    Site Not Available

  • Research Site

    Can Tho, 900000
    Vietnam

    Site Not Available

  • Research Site

    Can Tho 1586203, 900000
    Vietnam

    Site Not Available

  • Research Site

    Haiphong, 180000
    Vietnam

    Site Not Available

  • Research Site

    Haiphong 1581298, 180000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

    Site Not Available

  • Research Site

    Huế, 530000
    Vietnam

    Site Not Available

  • Research Site

    Huế 1580240, 530000
    Vietnam

    Site Not Available

  • Research Site

    Hà Nội, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hà Nội 8564175, 100000
    Vietnam

    Site Not Available

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