Recruiting

Phase 1

AZD3974A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants

Sponsor:

AstraZeneca

Code:

NCT07290283

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

AZD3974

Placebo

Study Details

Brief summary:

The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.

Conditions

Healthy Participants

Study ID

NCT07290283

Start date

Dec 10, 2025

Status verified date

Jul, 2026

Completion date

Oct 21, 2026

Anticipated

Primary completion date

Oct 21, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A1 (SAD) Cohort 1: AZD3974 (Dose 1)

Healthy participants will receive a single dose of AZD3974 - Dose 1

experimental: Part A1 (SAD) Cohort 2: AZD3974 (Dose 2)

Healthy participants will receive a single dose of AZD3974 - Dose 2

experimental: Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort)

Healthy participants will receive two single doses of AZD3974 - Dose 3

experimental: Part A1 (SAD) Cohort 4: AZD3974 (Dose 4)

Healthy participants will receive a single dose of AZD3974 - Dose 4

experimental: Part A1 (SAD) Cohort 5: AZD3974 (Dose 5)

Healthy participants will receive a single dose of AZD3974 - Dose 5

experimental: Part A1 (SAD) Cohort 6: AZD3974 (Dose 6)

Healthy participants will receive a single dose of AZD3974 - Dose 6

experimental: Part A1 (SAD) optional additional Cohort 7: AZD3974

Healthy participants will receive a single dose of AZD3974

experimental: Part A1 (SAD) optional additional Cohort 8: AZD3974

Healthy participants will receive a single dose of AZD3974

placebo comparator: Part A1 (SAD) Cohort: Placebo

Healthy participants will receive a single dose of matching placebo to AZD3974

placebo comparator: Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort)

Healthy participants will receive two single doses of matching placebo to AZD3974

experimental: Part A2 (SAD) Japanese Cohort 1: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

experimental: Part A2 (SAD) Japanese Cohort 2: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

experimental: Part A2 (SAD) Japanese Cohort 3: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

experimental: Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

placebo comparator: Part A2 (SAD) Japanese Cohort: Placebo

Healthy Japanese participants will receive a single dose of matching placebo to AZD3974

experimental: Part A3 (SAD) Chinese Cohort 1: AZD3974

Healthy Chinese participants will receive a single dose of AZD3974

experimental: Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974

Healthy Chinese participants will receive a single dose of AZD3974

placebo comparator: Part A3 (SAD) Chinese Cohort: Placebo

Healthy Chinese participants will receive a single dose of matching placebo to AZD3974

experimental: Part B1 (MAD) Cohort 1: AZD3974