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

NCT ID: NCT07290283

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-10-06

Brief Summary

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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.

Detailed Description

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This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts.

Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo.

Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo.

Both Part A and Part B will comprise of:

* A Screening Period of maximum 28 days
* A Dosing session during which participants will receive the study intervention at study specific time points.
* Follow-up Period of 7 days post last-dose.

Conditions

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Healthy Participants

Keywords

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Single ascending dose Multiple ascending dose Pharmacokinetics Impact of food First-in-human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

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

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

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

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

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

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

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

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

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

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A1 (SAD) optional additional Cohort 7: AZD3974

Healthy participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A1 (SAD) optional additional Cohort 8: AZD3974

Healthy participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A1 (SAD) Cohort: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be administered as an oral solution.

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be administered as an oral solution.

Part A2 (SAD) Japanese Cohort 1: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A2 (SAD) Japanese Cohort 2: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A2 (SAD) Japanese Cohort 3: AZD3974

Healthy Japanese participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

Healthy Japanese participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A2 (SAD) Japanese Cohort: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be administered as an oral solution.

Part A3 (SAD) Chinese Cohort 1: AZD3974

Healthy Chinese participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

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

Healthy Chinese participants will receive a single dose of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part A3 (SAD) Chinese Cohort: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be administered as an oral solution.

Part B1 (MAD) Cohort 1: AZD3974

Healthy participants will receive multiple doses of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B1 (MAD) Cohort 2: AZD3974

Healthy participants will receive multiple doses of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B1 (MAD) Cohort 3: AZD3974

Healthy participants will receive multiple doses of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B1 (MAD) Cohort 4: AZD3974

Healthy participants will receive multiple doses of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B1 (MAD) optional additional Cohort 5: AZD3974

Healthy participants will receive multiple doses of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B1 (MAD) optional additional Cohort 6: AZD3974

Healthy participants will receive multiple doses of AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part Bl (MAD) Cohort: Placebo

Healthy participants will receive multiple doses of matching placebo to AZD3974

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be administered as an oral solution.

Part B2 (MAD) Japanese Cohort 1: AZD3974

Healthy Japanese participants will receive multiple doses of AZD397

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974

Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974

Group Type EXPERIMENTAL

AZD3974

Intervention Type DRUG

AZD3974 will be administered as an oral solution.

Part B2 (MAD) Japanese Cohort: Placebo

Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be administered as an oral solution.

Interventions

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AZD3974

AZD3974 will be administered as an oral solution.

Intervention Type DRUG

Placebo

Placebo will be administered as an oral solution.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Glendale, California, United States

Site Status NOT_YET_RECRUITING

Research Site

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D7360C00001

Identifier Type: -

Identifier Source: org_study_id