AstraZeneca
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent.
This is a first-in-human, randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy participants and will be conducted at a single study center. It consists of two parts: Part A (Single Ascending Dose - SAD) and Part B (Multiple Ascending Dose - MAD). Part A of the study is a SAD sequential group design study and will consist of Parts A1, A2, and A3. Part A1 is planned to consist of 7 cohorts, Part A2 is planned to consist of one cohort of participants of Chinese descent, and Part A3 is planned to consist of 2 cohorts of participants of Japanese descent…
Inclusion Criteria: 1. Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture. 2. Negative pregnancy test at screening and admission (females only). 3. Females of non-childbearing potential confirmed by postmenopausal status or irreversible surgical sterilization. 4. Sexually active fertile males must use contraception methods from first administration until 3 months after the last follow-up visit. 5. Body mass index (BMI) between 18 and 32 kg/m² and weight at least 50 kg. 6. Participants of Chinese descent (Part A2) must have both…
AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study.
Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B of the study.
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