A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending-Dose Study to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of UPB-101 in Subjects With Asthma

  • STATUS
    Recruiting
  • End date
    Jul 15, 2023
  • participants needed
    40
  • sponsor
    Upstream Bio Inc.
Updated on 15 September 2022

Summary

The goals of this clinical study are to assess the safety, tolerability, blood levels, and disease impact of UPB-101 when given to adults with mild asthma. Eligible participant will be consecutively assigned to 1 of 5 planned treatment groups. Each treatment group will consist of 8 individuals, six of whom will receive active drug (UPB-101) and 2 who will be given placebo. Neither the study doctors nor the participants will know which participants were assigned to active study drug and which were assigned to placebo. The study will be performed at 3-4 experienced research sites in the United Kingdom.

Description

This is a two-part phase 1b, multi-center randomized, double-blind (Investigator and Subject blinded; Sponsor unblinded), placebo-controlled, multiple ascending-dose study to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of UPB-101 administered subcutaneously (SC) to adult subjects with asthma.

The study consists of Part A and Part B. Part A includes 3 cohorts with pre-set dosing regimens. Part B includes 2 cohorts whose doses and dosing intervals will be decided based upon the safety, PK, and PD results from Part A (i.e., an adaptive design). The regimens selected for Part B will not exceed the exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects will be randomized per cohort (6 active, 2 placebo). Thus, a total of approximately 40 subjects will be enrolled in the study with 24 subjects in Part A and 16 in Part B.

Details
Condition Asthma
Treatment Placebo, UPB-101
Clinical Study IdentifierNCT05448651
SponsorUpstream Bio Inc.
Last Modified on15 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged 18 to 55, and has physician-diagnosed asthma
Body mass index (BMI) between 18 and 35 kg/m2
Blood eosinophil cell count ≥200 at one screening visit and ≥150 at the other screening
Agrees to follow the required contraceptive techniques
Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug
Able to perform spirometry (breathing tests)
Asthma and non-biologic asthma medication have been stable for the past 2 months
Fully vaccinated in accordance with all current national vaccination policies

Exclusion Criteria

Employee, consultant, and/or immediate family member of any person involved in the conduct of the study
Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients
Pregnant or breastfeeding female
Unable to fast and avoid strenuous exercise for 9 hours prior to each site visit
Serious allergic reaction to any injected drug
Significantly abnormal clinical laboratory test results or a significant medical condition
Recently donated blood (including blood products) or experienced significant loss of blood
Has pacemaker or a significantly abnormal electrocardiogram
An active or a serious infection in the past 8 weeks
Poorly-controlled diabetes or abnormal kidney function
Tests positive to illicit drugs or nicotine and cannot limit alcohol consumption
Tests positive for human immunodeficiency virus antibodies (HIV), hepatitis B, hepatitis C antibodies, or tuberculosis
Received any vaccine within the past month
Received any immunosuppressant therapies in the past
Received an antibody or therapeutic biologic product in the last 6 months
Received steroids (other than inhaled) in the past 2 months
Participated recently in a clinical study
Current tobacco smokers or has smoked within the last year
Tested positive for COVID-19 in the past month
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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