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

NCT ID: NCT05448651

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2023-10-05

Brief Summary

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

Detailed Description

This was 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 included 3 cohorts with pre-set dosing regimens. Part B (optional) included up to 2 additional cohorts whose doses and dosing intervals decided based upon the safety, PK, and PD results from Part A (i.e., an adaptive design), as applicable. The regimens selected for Part B did not exceed the exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects were randomized per cohort (6 active, 2 placebo). Thus, a total of 32 subjects were enrolled in the study with 24 subjects in Part A and 8 in Part B.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active substance 1

UPB-101 Cohort 1

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

Subcutaneous injection

Placebo

Intervention Type: DRUG

Subcutaneous injection

Active substance 2

UPB-101 Cohort 2

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

Subcutaneous injection

Placebo

Intervention Type: DRUG

Subcutaneous injection

Active substance 3

UPB-101 Cohort 3

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

Subcutaneous injection

Placebo

Intervention Type: DRUG

Subcutaneous injection

Active Substance 4

UPB-101 Cohort 4

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

Subcutaneous injection

Placebo

Intervention Type: DRUG

Subcutaneous injection

Interventions

UPB-101

Subcutaneous injection

Intervention Type: DRUG

Placebo

Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Formerly ASP7266; 0.9% saline solution

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged 18 to 60, and has physician-diagnosed asthma

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

3. Blood eosinophil cell count ≥200 (OR ≥150 combined with fractional exhaled nitric oxide [a measure of lung airway inflammation] >25) 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Upstream Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sumathi Sivapalasingam, MD

Role: STUDY_DIRECTOR

Upstream Bio

Locations

Hammersmith Medicines Research

London, , United Kingdom

Queen Anne Street Medical Centre

London, , United Kingdom

Richmond Pharmacology

London, , United Kingdom

Medicines Evaluation Unit

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UPB-CP-01

Identifier Type: -

Identifier Source: org_study_id