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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06980428
Brief Summary:
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\[a\]) levels.
Detailed Description:
This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female (of non-childbearing potential) participants (Part A) or healthy participants (of non-childbearing potential) with elevated Lp(a) levels (≥ 30 mg/dL; Part B).
The study consists of 2 parts: Part A (SAD) and Part B (MAD).
Part A of the study will consist of Part A1 and Part A2, comprising:
* A Screening Period of maximum 28 days.
* Admission to study site (Day -1).
* A Treatment Period (Day 1 to Day 15 at the study site) with a single dose of AZD4954 or placebo on Day 1.
* A Follow-up Visit within 26 to 30 days after the investigational medicinal product (IMP) dose for all cohorts (Day 29 ±2 days).
Part B of the study will comprise:
* A Screening Period of maximum 28 days.
* Admission to study site (Day -1).
* A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21) in the global MAD cohorts and for 14 days (Day 1 to 14) in Japanese MAD cohorts.
* A Follow-up Visit within 26 to 30 days after the last IMP dose (Day 49 ±2 days for the global MAD cohorts and Day 42 ±2 days for the Japanese MAD cohorts).
Study:
NCT06980428
Study Brief:
Protocol Section:
NCT06980428