Study of Safety and PK of AZD0543 in Healthy Adults

Conditions

• Human Metapneumovirus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• AZD0543 — BIOLOGICAL
  Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
• Placebo — OTHER
  Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.

Study Details

The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.

Key Dates

First listed

Sep 17, 2026

Start date

Aug 31, 2026

Status verified

Sep 2026

Primary completion

Mar 24, 2027

Completion

Dec 20, 2027

Study Design

Enrollment

144 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Cohort 1: Low Dose AZD0543
  Participants will receive a single AZD0543 dose.
• Placebo Comparator: Cohort 1: Placebo
  Participants will receive a single dose of placebo.
• Experimental: Cohort 2: Medium Dose AZD0543
  Participants will receive a single AZD0543 dose.
• Placebo Comparator: Cohort 2: Placebo
  Participants will receive a single dose of placebo.
• Experimental: Cohort 3: High Dose AZD0543
  Participants will receive a single AZD0543 dose.
• Placebo Comparator: Cohort 3: Placebo
  Participants will receive a single dose of placebo.

Primary Outcome Measure

Immediate AEs within 1 hour of IMP administration [ Time Frame: Within 1 hour of IMP administration ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (2)