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Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics

Sponsor
Upstream Bio Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05448651
Collaborator
(none)
40
Enrollment
1
Location
5
Arms
12.1
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 27, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active substance 1

UPB-101 Cohort 1

Drug: UPB-101
Subcutaneous injection
Other Names:
  • Formerly ASP7266

    • Drug: Placebo
    Subcutaneous injection
    Other Names:
  • 0.9% saline solution

    		•
    Experimental: Active substance 2

    UPB-101 Cohort 2

    Drug: UPB-101
    Subcutaneous injection
    Other Names:
  • Formerly ASP7266

    • Drug: Placebo
    Subcutaneous injection
    Other Names:
  • 0.9% saline solution

    		•
    Experimental: Active substance 3

    UPB-101 Cohort 3

    Drug: UPB-101
    Subcutaneous injection
    Other Names:
  • Formerly ASP7266

    • Drug: Placebo
    Subcutaneous injection
    Other Names:
  • 0.9% saline solution

    		•
    Experimental: Active Substance 4

    UPB-101 Cohort 4

    Drug: UPB-101
    Subcutaneous injection
    Other Names:
  • Formerly ASP7266

    • Drug: Placebo
    Subcutaneous injection
    Other Names:
  • 0.9% saline solution

    		•
    Experimental: Active substance 5

    UPB-101 Cohort 5

    Drug: UPB-101
    Subcutaneous injection
    Other Names:
  • Formerly ASP7266

    • Drug: Placebo
    Subcutaneous injection
    Other Names:
  • 0.9% saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-emergent adverse events and serious adverse events [Baseline through 24 weeks]

    Secondary Outcome Measures

    1. Incidence of anti-drug antibodies [Baseline through 24 weeks]

    2. Titer of anti-drug antibodies [Baseline through 24 weeks]

    3. Maximum observed concentration of UPB-101 [Baseline through 24 weeks]

    4. Time to maximum observed concentration of UPB-101 [Baseline through 24 weeks]

    5. Area under the concentration-time curve under one dosing interval of UPB-101 [Baseline through 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female, aged 18 to 55, and has physician-diagnosed asthma

    2. Body mass index (BMI) between 18 and 35 kg/m2

    3. Blood eosinophil cell count ≥200 at one screening visit and ≥150 at the other screening

    4. Agrees to follow the required contraceptive techniques

    5. 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

    6. Able to perform spirometry (breathing tests)

    7. Asthma and non-biologic asthma medication have been stable for the past 2 months

    8. Fully vaccinated in accordance with all current national vaccination policies

    Exclusion Criteria:

    1. Employee, consultant, and/or immediate family member of any person involved in the conduct of the study

    2. Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients

    3. Pregnant or breastfeeding female

    4. Unable to fast and avoid strenuous exercise for 9 hours prior to each site visit

    5. Serious allergic reaction to any injected drug

    6. Significantly abnormal clinical laboratory test results or a significant medical condition

    7. Recently donated blood (including blood products) or experienced significant loss of blood

    8. Has pacemaker or a significantly abnormal electrocardiogram

    9. An active or a serious infection in the past 8 weeks

    10. Poorly-controlled diabetes or abnormal kidney function

    11. Tests positive to illicit drugs or nicotine and cannot limit alcohol consumption

    12. Tests positive for human immunodeficiency virus antibodies (HIV), hepatitis B, hepatitis C antibodies, or tuberculosis

    13. Received any vaccine within the past month

    14. Received any immunosuppressant therapies in the past

    15. Received an antibody or therapeutic biologic product in the last 6 months

    16. Received steroids (other than inhaled) in the past 2 months

    17. Participated recently in a clinical study

    18. Current tobacco smokers or has smoked within the last year

    19. Tested positive for COVID-19 in the past month

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicines Evaluation Unit Manchester United Kingdom

    Sponsors and Collaborators

    • Upstream Bio Inc.

    Investigators

    • Study Director: Chaim M Brickman, MD, Upstream Bio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Upstream Bio Inc.
    ClinicalTrials.gov Identifier:
    NCT05448651
    Other Study ID Numbers:
    • UPB-CP-01
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Jul 28, 2022