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, and Participants With Dyslipidemia
AstraZeneca
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 and participants with dyslipidemia.
Description
This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female participants (Part A) or healthy participants with elevated Lp(a) levels (≥ 30 mg/dL) and participants with dyslipidemia with elevated Lp(a) levels (≥ 70 mg/dL) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL and \< 190 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 Treat…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: All Parts: * Participants with plasminogen level (concentration) within normal range at the Screening Visit. * All females must have a negative pregnancy test at the Screening Visit and on admission to the study site. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception. * Females of non-childbearing potential must be confirmed at the Screening Visit. * Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific c…
Interventions
- DrugAZD4954
AZD4954 will be administered orally.
- DrugPlacebo
Placebo will be administered orally.
Locations (6)
- Research SiteGlendale, California
- Research SiteInverness, Florida
- Research SiteJacksonville, Florida
- Research SitePort Orange, Florida
- Research SiteBrooklyn, Maryland
- Research SiteSan Antonio, Texas