NCT06639997

Safety and Tolerability of AZD5148 in Japanese Participants

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Japanese Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.

Detailed description

The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants. Study details include: • There will be 12 planned visits (including screening visit) over a period of up to 56 weeks.

Conditions

• Clostridioides Difficile Infection

Interventions

Type	Name	Description
DRUG	AZD5148	Participants will receive AZD5148 as IM injection or IV bolus
DRUG	Placebo	Participants will receive matching doses of placebo as an IM injection or IV bolus

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2024-10-15
• Last updated: 2026-01-30

Locations

1 site across 1 country: Japan