Healthy Subjects (Indication: Asthma) Clinical Trial
Official title:
A Phase 1, Randomised, Single-blind, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Elarekibep Given Twice Daily as Inhaled or a Single IV Formulation in Healthy Japanese Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo.
This is a Phase I, randomised, single-blind, placebo-controlled, single-centre study. This study comprises upto a total of 42 subjects. This study consists of two parts: A single dose part (Part A1 and Part A2) and a multiple dose part (Part B). Part A and Part B will comprise of the following: - Each subject will be involved in the study for up to 9 weeks if enrolled in Part A and up to 10 weeks if enrolled in Part B. - A screening period of maximum 28 days. - Treatment period: Part A: Study treatment Day 1; Part B: Study treatment Days 1 to 6 and a single inhaled dose on Day 7. - A safety follow-up call will be conducted 7 (± 1) days after elarekibep or placebo administration. - A safety follow-up visit will be conducted 30 (± 2) days after elarekibep or placebo administration in each cohort. ;