Healthy Volunteers Clinical Trial
Official title:
A Phase I, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AZD1163 Administered as Single and Multiple Ascending Doses in Healthy Volunteers
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks. The study will comprise of: - A Screening Period of maximum 28 days for both Part 1 and Part 2. - Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days. - Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days. - An outpatient Follow-up Period of approximately 15 months. ;
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