A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT06103877
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD1163 — BIOLOGICAL
    In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1. In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
  • Placebo — OTHER
    In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1. In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.

Study Details

A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.

Key Dates

Start date
Nov 1, 2023
Status verified
Jan 2026
Primary completion
Jan 13, 2026
Completion
Jan 13, 2026

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Part 1 Cohort 1 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 2 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 3 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 4 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 5a SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 5b SAD
    Participants will receive SC injection of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 6 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 7 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Active Comparator: Part 1 Cohort 8 SAD
    Participants will receive IV infusion of AZD1163 on Day 1.
  • Placebo Comparator: Part 1 Pooled Placebo SAD IV
    Participants will receive matching IV infusion of placebo on Day 1.
  • Placebo Comparator: Part 1 Placebo SAD SC
    Participants will receive matching SC injection of placebo on Day 1.
  • Active Comparator: Part 1 Cohort 9 SAD (Chinese Participants)
    Participants will receive SC injection of AZD1163 on Day 1.
  • Placebo Comparator: Part 1 Placebo SAD (Chinese Participants)
    Participants will receive matching SC injection of placebo on Day 1.
  • Active Comparator: Part 2 Cohort 1 MAD (Global)
    Participants will receive SC injection of AZD1163 on Days 1 and 15.
  • Active Comparator: Part 2 Cohort 2 MAD (Global)
    Participants will receive SC injection of AZD1163 on Days 1 and 15.
  • Placebo Comparator: Part 2 Placebo MAD (Global)
    Participants will receive matching SC injection of placebo on Days 1 and 15.
  • Active Comparator: Part 2 Cohort 3 MAD (Chinese Participants)
    Participants will receive SC injection of AZD1163 on Days 1 and 15.
  • Active Comparator: Part 2 Cohort 4 MAD (Japanese participants)
    Participants will receive SC injection of AZD1163 on Days 1 and 15.
  • Placebo Comparator: Part 2 Placebo MAD (Chinese participants)
    Participants will receive matching SC injection of placebo on Days 1 and 15.
  • Placebo Comparator: Part 2 Placebo MAD (Japanese participants)
    Participants will receive matching SC injection of placebo on Days 1 and 15.

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: From Day -1 until end of study (Day 450) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBrooklynMaryland21225-

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

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