Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT06995820
Brief 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.
Detailed 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 6 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.
Parts A1, A2, and A3 of the study will comprise of:
1. A Screening Period of maximum 28 days.
2. A Treatment Period during which each participant will receive a single subcutaneous (SC) or intravenous (IV) dose of either AZD1613 or placebo on Day 1.
3. A Follow-up Period where participants will return to the study center for non-residential visits until Day 105.
Part B of the study will be a MAD sequential group design study. Up to 3 dose levels of AZD1613 are planned to be investigated in 3 cohorts of healthy participants.
Part B of the study will comprise of:
1. A Screening Period of maximum 28 days.
2. Three Treatment Periods during which participants will receive 3 single subcutaneous (SC) or intravenous (IV) doses of AZD1613 or placebo at 28-day intervals (Day 1, Day 29, and Day 57).
3. A Follow-up Period where participants will return to the study center for non-residential visits until Day 161.
Study:
NCT06995820
Study Brief:
Protocol Section:
NCT06995820