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

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT07290283
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD3974 — DRUG
    AZD3974 will be administered as an oral solution.
  • Placebo — OTHER
    Placebo will be administered as an oral solution.

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
May 2026
Primary completion
Oct 21, 2026
Completion
Oct 21, 2026

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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
    Healthy participants will receive multiple doses of AZD3974
  • Experimental: Part B1 (MAD) Cohort 2: AZD3974
    Healthy participants will receive multiple doses of AZD3974
  • Experimental: Part B1 (MAD) Cohort 3: AZD3974
    Healthy participants will receive multiple doses of AZD3974
  • Experimental: Part B1 (MAD) Cohort 4: AZD3974
    Healthy participants will receive multiple doses of AZD3974
  • Experimental: Part B1 (MAD) optional additional Cohort 5: AZD3974
    Healthy participants will receive multiple doses of AZD3974
  • Experimental: Part B1 (MAD) optional additional Cohort 6: AZD3974
    Healthy participants will receive multiple doses of AZD3974
  • Placebo Comparator: Part Bl (MAD) Cohort: Placebo
    Healthy participants will receive multiple doses of matching placebo to AZD3974
  • Experimental: Part B2 (MAD) Japanese Cohort 1: AZD3974
    Healthy Japanese participants will receive multiple doses of AZD397
  • Experimental: Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974
    Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974
  • Placebo Comparator: Part B2 (MAD) Japanese Cohort: Placebo
    Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974

Primary Outcome Measure

Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBaltimoreMaryland21225-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CAResearch Site· Baltimore, MD

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