NCT07290283

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_1

Timeline
6mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Dec 2025Oct 2026

First Submitted

Initial submission to the registry

December 5, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

December 5, 2025

Last Update Submit

April 24, 2026

Conditions

Healthy Participants

Keywords

Single ascending doseMultiple ascending dosePharmacokineticsImpact of foodFirst-in-human

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants

    Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14

Secondary Outcomes (41)

  • Part A and Part B: Plasma concentrations of AZD3974

    Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

  • Part A1-Cohort 3: Plasma concentrations of AZD3974

    Day 1 to Day 4

  • Part A and Part B: Urine concentrations of AZD3974

    Part A: Day 1; Part B: Day 1 and Day 7

  • Part A1-Cohort 3: Urine concentrations of AZD3974

    Day 1 and Day 3

  • Part A and Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    Part A: Day 1 to Day 2; Part B: Day 1 to Day 9

  • +36 more secondary outcomes

Study Arms (28)

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

EXPERIMENTAL

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

Drug: AZD3974

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

EXPERIMENTAL

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

Drug: AZD3974

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

EXPERIMENTAL

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

Drug: AZD3974

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

EXPERIMENTAL

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

Drug: AZD3974

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

EXPERIMENTAL

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

Drug: AZD3974

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

EXPERIMENTAL

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

Drug: AZD3974

Part A1 (SAD) optional additional Cohort 7: AZD3974

EXPERIMENTAL

Healthy participants will receive a single dose of AZD3974

Drug: AZD3974

Part A1 (SAD) optional additional Cohort 8: AZD3974

EXPERIMENTAL

Healthy participants will receive a single dose of AZD3974

Drug: AZD3974

Part A1 (SAD) Cohort: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

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

PLACEBO COMPARATOR

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

Other: Placebo

Part A2 (SAD) Japanese Cohort 1: AZD3974

EXPERIMENTAL

Healthy Japanese participants will receive a single dose of AZD3974

Drug: AZD3974

Part A2 (SAD) Japanese Cohort 2: AZD3974

EXPERIMENTAL

Healthy Japanese participants will receive a single dose of AZD3974

Drug: AZD3974

Part A2 (SAD) Japanese Cohort 3: AZD3974

EXPERIMENTAL

Healthy Japanese participants will receive a single dose of AZD3974

Drug: AZD3974

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

EXPERIMENTAL

Healthy Japanese participants will receive a single dose of AZD3974

Drug: AZD3974

Part A2 (SAD) Japanese Cohort: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Part A3 (SAD) Chinese Cohort 1: AZD3974

EXPERIMENTAL

Healthy Chinese participants will receive a single dose of AZD3974

Drug: AZD3974

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

EXPERIMENTAL

Healthy Chinese participants will receive a single dose of AZD3974

Drug: AZD3974

Part A3 (SAD) Chinese Cohort: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Part B1 (MAD) Cohort 1: AZD3974

EXPERIMENTAL

Healthy participants will receive multiple doses of AZD3974

Drug: AZD3974

Part B1 (MAD) Cohort 2: AZD3974

EXPERIMENTAL

Healthy participants will receive multiple doses of AZD3974

Drug: AZD3974

Part B1 (MAD) Cohort 3: AZD3974

EXPERIMENTAL

Healthy participants will receive multiple doses of AZD3974

Drug: AZD3974

Part B1 (MAD) Cohort 4: AZD3974

EXPERIMENTAL

Healthy participants will receive multiple doses of AZD3974

Drug: AZD3974

Part B1 (MAD) optional additional Cohort 5: AZD3974

EXPERIMENTAL

Healthy participants will receive multiple doses of AZD3974

Drug: AZD3974

Part B1 (MAD) optional additional Cohort 6: AZD3974

EXPERIMENTAL

Healthy participants will receive multiple doses of AZD3974

Drug: AZD3974

Part Bl (MAD) Cohort: Placebo

PLACEBO COMPARATOR

Healthy participants will receive multiple doses of matching placebo to AZD3974

Other: Placebo

Part B2 (MAD) Japanese Cohort 1: AZD3974

EXPERIMENTAL

Healthy Japanese participants will receive multiple doses of AZD397

Drug: AZD3974

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

EXPERIMENTAL

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

Drug: AZD3974

Part B2 (MAD) Japanese Cohort: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AZD3974DRUG

AZD3974 will be administered as an oral solution.

Part A1 (SAD) Cohort 1: AZD3974 (Dose 1)Part A1 (SAD) Cohort 2: AZD3974 (Dose 2)Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort)Part A1 (SAD) Cohort 4: AZD3974 (Dose 4)Part A1 (SAD) Cohort 5: AZD3974 (Dose 5)Part A1 (SAD) Cohort 6: AZD3974 (Dose 6)Part A1 (SAD) optional additional Cohort 7: AZD3974Part A1 (SAD) optional additional Cohort 8: AZD3974Part A2 (SAD) Japanese Cohort 1: AZD3974Part A2 (SAD) Japanese Cohort 2: AZD3974Part A2 (SAD) Japanese Cohort 3: AZD3974Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974Part A3 (SAD) Chinese Cohort 1: AZD3974Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974Part B1 (MAD) Cohort 1: AZD3974Part B1 (MAD) Cohort 2: AZD3974Part B1 (MAD) Cohort 3: AZD3974Part B1 (MAD) Cohort 4: AZD3974Part B1 (MAD) optional additional Cohort 5: AZD3974Part B1 (MAD) optional additional Cohort 6: AZD3974Part B2 (MAD) Japanese Cohort 1: AZD3974Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974
PlaceboOTHER

Placebo will be administered as an oral solution.

Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort)Part A1 (SAD) Cohort: PlaceboPart A2 (SAD) Japanese Cohort: PlaceboPart A3 (SAD) Chinese Cohort: PlaceboPart B2 (MAD) Japanese Cohort: PlaceboPart Bl (MAD) Cohort: Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, 91206, United States

NOT YET RECRUITING

Research Site

Baltimore, Maryland, 21225, United States

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

October 21, 2026

Study Completion (Estimated)

October 21, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(2)