Phase 1 - To Assess PK, Safety & Tolerability of Elarekibep in Healthy Japanese Subjects
Research type
Research Study
Full 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
IRAS ID
1005055
Contact name
Danielle Steele
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-000426-22
Clinicaltrials.gov Identifier
Research summary
This is A Phase 1, Randomised, Single-blind, Placebo-controlled, Single centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of AZD1402 Given Twice Daily as Inhaled or a Single IV Formulation in Healthy Japanese Subjects. The new medicine tested in this clinical trial is a compound called AZD1402. The Sponsor is developing the clinical trial medicine as inhaled therapy for the treatment of moderate to severe persistent asthma for patients that are not controlled on standard of care therapies.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of AZD1402 after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects, compared with placebo. Healthy Japanese subjects were selected to enable the Japanese population to be part of the global development program of AZD1402.
The study will consist of two parts: A single dose part (Part A1 and Part A2) and a multiple dose part (Part B).
In Part A1, 24 subjects, randomised in 4 treatment arms, will receive a single inhaled dose of AZD1402 or placebo. In Part A2, 6 subjects will receive a single IV dose of AZD1402. In Part B, after completion of Part A, another 12 subjects will receive multiple inhaled doses of AZD1402 or placebo BID on Days 1 to 6 and a single inhaled dose on Day 7.
In Part A1, 24 subjects will be randomised to receive a single dose of either 1 mg AZD1402 (N = 6), 3 mg AZD1402 (N = 6), 10 mg AZD1402 (N = 6) or placebo.
In Part A2, 6 subjects will receive an IV dose of AZD1402 with no placebo subjects.
In Part B, 12 subjects will be randomised, 9 will receive AZD1402 and 3 will receive placebo.
This is not a first-in-human trial as the study medication has been given to humans before in clinical trials.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0453
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion