A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of AZD1613 Following Single and Multiple Dose Administration in Healthy Participants
AstraZeneca
Summary
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.
Description
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…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugAZD1613
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.
- DrugPlacebo
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.
Location
- Research SiteGlendale, California