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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Upstream Bio Inc.

Criteria

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