A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT06995820
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • AZD1613 — DRUG
    AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study.
  • Placebo — DRUG
    Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B of the study.

Study Details

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent.

Key Dates

Start date
Jun 6, 2025
Status verified
May 2026
Primary completion
Sep 23, 2026
Completion
Sep 23, 2026

Study Design

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

Arms

  • Experimental: Part A1 (SAD): AZD1613 (Dose 1) SC
    Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1.
  • Experimental: Part A1 (SAD): AZD1613 (Dose 2) SC
    Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1.
  • Experimental: Part A1 (SAD): AZD1613 (Dose 3) SC
    Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1.
  • Experimental: Part A1 (SAD): AZD1613 (Dose 4) SC
    Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1.
  • Experimental: Part A1 (SAD): AZD1613 (Dose 5) IV
    Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1.
  • Experimental: Part A1 (SAD): AZD1613 (Dose 6) IV
    Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1.
  • Experimental: Part A1 (SAD): AZD1613 (Dose 7) IV
    Participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as an IV infusion on Day 1.
  • Experimental: Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese)
    Chinese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as an IV infusion on Day 1.
  • Experimental: Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese)
    Japanese participants will receive a single dose of AZD1613 (Dose 9) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.
  • Experimental: Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese)
    Japanese participants will receive a single dose of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.
  • Experimental: Part B (MAD): AZD1613 (Dose 11) SC or IV
    Participants will receive multiple doses of AZD1613 (Dose 11) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57.
  • Experimental: Part B (MAD): AZD1613 (Dose 12) IV
    Participants will receive multiple doses of AZD1613 (Dose 12) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57.
  • Experimental: Part B (MAD): AZD1613 (Dose 13) IV
    Participants will receive multiple doses of AZD1613 (Dose 13) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57.

Primary Outcome Measure

Number of participants with adverse events (AEs) and serious AEs. [ Time Frame: AEs: Part A: From Day 1 to Final Follow-up (Day 105); Part B: From Day 1 to Final Follow-up (Day 161); SAEs: Part A: From Screening (Day -28 to Day -2) to Final Follow-up visit (Day 105) Part B: From Screening (Day -28) to Final Follow-up visit (Day 161) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-

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Research Site· Glendale, CA

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