A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels

Launched by ASTRAZENECA · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AZD4954 to see how safe it is and how the body handles it in healthy adults. The researchers want to understand how the drug works, especially in people who may have higher levels of a substance called Lipoprotein(a) or Lp(a). This study will include both healthy individuals with normal Lp(a) levels and those with elevated levels, and it will be conducted in two parts.

To participate, individuals must be between the ages of 18 and 35, have a healthy body weight, and meet some additional health criteria, including having normal blood levels of certain proteins. Women need to have a negative pregnancy test, and sexually active men must use contraception during the study. Participants will receive either a single dose or multiple doses of the medication, and the study will monitor their health closely for safety. This trial is not yet recruiting participants, but it aims to gather important information that could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Parts A and B:
• • 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 Clinical Unit.
• • 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 contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
• • Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive.
• * For Japanese and Chinese participants (Parts A and B):
• • 1. A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
• • 2. A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
• Only Part B:
• • For Part B (Global MAD Cohorts), at the Screening Visit participants must have elevated Lp(a) ≥ 30 mg/dL.
• Exclusion Criteria:
• Parts A and B:
• • History of any clinically important disease or disorder.
• • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
• • Participants with known bleeding or coagulation disorders.
• • Participants who have an elevated high-sensitivity C-reactive protein (\> 3 mg/L) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) \> 1.25 times × upper limit normal (ULN).
• • Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.
• • Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or human immunodeficiency virus (HIV).
• • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
• • Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.