A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.

Key facts

Study ID

NCT06122714

Run by

AstraZeneca

People needed

95

Starts

2023-11-07

Expected to finish

2024-12-04

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females must have a negative pregnancy test, must not be lactating and must be of non-childbearing potential.
• Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.
• For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female (of non-childbearing potential) participants are to be Japanese, defined as having both parents and four grandparents who are Japanese. This included second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
• For healthy Chinese cohort (Part A3): healthy male and female (of non-childbearing potential) Chinese participants for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years.

You may not qualify if…

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study.
• 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.
• Clinically significant serious active and chronic infections.
• Bacillus Calmette-Guérin vaccine within one year prior to signing the ICF.
• Any abnormal laboratory values at the Screening Visit.
• Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc), hepatitis C antibody, or Human Immunodeficiency Virus (HIV).
• Any cardiac abnormalities.
• History of alcohol abuse or drug abuse.
• Current smokers or those who have smoked or used nicotine products.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• Clinical signs and symptoms consistent with COVID-19.
• In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
• Previous bone marrow transplant
• Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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