Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 3:44 AM
Study NCT ID:
NCT06980428
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: