AZD3974 safety and pharmacokinetics in healthy adults

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants

This trial will test whether AZD3974 is safe and well tolerated and how the body absorbs and clears it in healthy adults, including people of Japanese and Chinese descent, using single and multiple ascending oral doses and a food-effect check.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 2 sites (Glendale, California and 1 other locations)
• Trial ID: NCT07290283 on ClinicalTrials.gov

What this trial studies

This first-in-human, randomized, single-blind, placebo-controlled protocol has two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Part A (SAD) enrolls several cohorts of general healthy participants and dedicated cohorts of Japanese and Chinese descent, including a cohort with a food-effect evaluation. Part B (MAD) enrolls multiple cohorts of healthy participants and a Japanese cohort to evaluate repeat dosing safety and pharmacokinetics. Each participant completes screening (up to 28 days), a dosing session, and a 7-day follow-up after the last dose with intensive safety and PK sampling.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with BMI 18–32 kg/m2 and weight ≥50 kg who have suitable veins for blood sampling, are not pregnant (or are females of non-childbearing potential), and for specific cohorts meet the protocol's Japanese or Chinese ancestry definitions.

Not a fit: People with active medical conditions, pregnant or breastfeeding women, females of childbearing potential without confirmed permanent contraception, or those outside the required BMI/weight ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify safe dose ranges and inform future trials that test AZD3974 in patients who might benefit from the drug's effects.

How similar studies have performed: Single- and multiple-ascending-dose first-in-human PK/safety studies are a standard and generally successful approach to define dosing and tolerability for new drugs, but AZD3974 itself has not been tested in humans before.

Eligibility criteria

Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
* All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
* For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes 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 Chinese participants for whom both parents and 4 grandparents are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.

Exclusion Criteria:

* History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate 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 within 4 weeks of the first administration of study intervention.
* Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
* Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiography at Screening and/or admission to the Clinical Unit .
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* Positive screen for drugs of abuse, or alcohol, or cotinine.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Participants who have previously received AZD3974.

Where this trial is running

Glendale, California and 1 other locations

• Research Site — Glendale, California, United States (Not_yet_recruiting)
• Research Site — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Single ascending dose; Multiple ascending dose; Pharmacokinetics; Impact of food; First-in-human