Full name
A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B (anti-IL33) Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease
NCT Number
NCT06154837
Geography
US
Non-US
Locations
Germany, United Kingdom, United States
Primary Endpoints
- Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). Up to 36 weeks
- Part B: Number of Participants with AEs and SAEs. Up to 48 weeks
- Part A: Number of Participants with Clinically significant changes in laboratory values. Up to 28 weeks
- Part A: Number of Participants with Clinically Significant Change in vital signs. Up to 28 weeks
- Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters. Up to 28 weeks
- Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis). Up to 42 weeks
- Part B: Number of Participants with Clinically Significant Change in vital signs. Up to 42 weeks
- Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters. Up to 42 weeks
Order
5
Disease
Version
Phase
1
Status
Recruiting