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

NCT06122714

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: AZD4144 Part A, AZD4144 Part B, Placebo Part A, Placebo Part B

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* 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:

1. Previous bone marrow transplant
2. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection

Locations (2)

Glendale, California, United States
Brooklyn, Maryland, United States