Phase
Condition
Lung Injury
Scar Tissue
Idiopathic Pulmonary Fibrosis
Treatment
PMG1015 placebo
PMG1015
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Diagnosis of IPF as defined by current American Thoracic Society (ATS)/EuropeanRespiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American ThoracicAssociation (ALAT) Clinical Practice Guidelines for IPF (2022) (Pathologicalexamination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lungbiopsy);
Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin)from 30% to 90% of the predicted, inclusive at screening;
Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons
Exclusion
Key Exclusion Criteria:
Patients with instable condition of IPF as assessed by the investigator atscreening, and those with acute exacerbation of IPF during screening or within 3months prior to randomization;
Patients who are likely to be lung transplant recipients within 6 months or expectedto survive less than 1 year as assessed by the investigator at screening;
Patients accompanying with an interstitial lung disease other than IPF;
Patients accompanying with other types of respiratory disorders, which may affectthe study results as assessed by the investigator;
Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g.Bosentan) within 1 month prior to screening;
Patients accompanying with other uncontrolled underlying diseases, for which thepatient is not considered suitable for the study as assessed by the investigator;
Patients who had active tuberculosis within 12 months prior to screening, orclinical symptoms of bacterial, viral, fungal or microbial infections requiringintervention within 4 weeks prior to randomization;
Patients who have known allergic reaction to the investigational product or itsactive pharmaceutical ingredients (APIs), or history of allergic reaction to human,humanized, chimeric, or murine monoclonal antibodies or any substances contained inthe excipients;
Pregnant or lactating women; female subjects who plan to become pregnant during thestudy, or patients who are not willing to take contraceptive measures as required bythe protocol during the study;
Other conditions that preclude the patient from participating in the study asassessed by the investigator.
Study Design
Connect with a study center
Site 07
Hefei, Anhui 230000
ChinaActive - Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui 230000
ChinaActive - Recruiting
China-Japan Friendship Hospital
Beijing, Beijing 100029
ChinaActive - Recruiting
Site 01
Beijing, Beijing 100029
ChinaActive - Recruiting
Site 06
Guangzhou, Guangdong 510120
ChinaActive - Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong 510120
ChinaActive - Recruiting
Site 03
Wuhan, Hubei 430030
ChinaActive - Recruiting
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei 430030
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
Site 04
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaActive - Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Site 02
Shanghai, Shanghai 200030
ChinaActive - Recruiting
Site 05
Shanghai, Shanghai 200433
ChinaActive - Recruiting
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