Phase
Condition
N/ATreatment
Placebo
AZD4954
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Parts A and B:
Participants with plasminogen level (concentration) within normal range at theScreening Visit.
All females must have a negative pregnancy test at the Screening Visit and onadmission 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 potentialmust adhere to the study specific contraception methods from the time of firstadministration 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):
A Japanese participant is defined as having both parents and 4 grandparents whoare ethnically Japanese. This includes second and third generation Japanesewhose parents or grandparents are living in a country other than Japan.
A Chinese participant is defined as having both parents and 4 grandparents whoare ethnically Chinese. This includes second and third generation Chinese whoseparents 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 haveelevated Lp(a) ≥ 30 mg/dL.
Exclusion
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 othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.
Any clinically important illness, medical/surgical procedure, or trauma within 4weeks 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) orhave a prothrombin time/international normalized ratio (PT/INR) or activated partialthromboplastin time (aPTT) > 1.25 times × upper limit normal (ULN).
Any clinically important abnormalities in hematology, coagulation, clinicalchemistry, 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), hepatitis C virus (HCV) or human immunodeficiencyvirus (HIV).
Any clinically important abnormalities in rhythm, conduction, or morphology of theresting 12-lead electrocardiogram (ECG) at Screening.
Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeksprior to the first administration of study intervention.
Study Design
Study Description
Connect with a study center
Research Site
Glendale, California 91206
United StatesSite Not Available
Research Site
Glendale 5352423, California 5332921 91206
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32216
United StatesSite Not Available
Research Site
Inverness 4159786, Florida 4155751 34452
United StatesSite Not Available
Research Site
Jacksonville 4160021, Florida 4155751 32216
United StatesSite Not Available
Research Site
Brooklyn, Maryland 21225
United StatesSite Not Available
Research Site
Brooklyn 4349594, Maryland 4361885 21225
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78229
United StatesSite Not Available
Research Site
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
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