NCT06093542

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.

A Randomised, Single-blind, Single Center, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.

Detailed description

This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously. The study will comprise of: * A screening period of 28 days. * Randomization on Day 1. * A 9-week Treatment Period. Dose 1 will be administered on Day 1. Dose 2 will be administered at the study site on Day 29. Dose 3 will be administered on Day 57. * A follow-up period of 10 week after last dose of study intervention. * The total duration of the study will be 23 weeks

Conditions

• Heathy Participants

Interventions

Type	Name	Description
DRUG	AZD7053	Randomised participants will receive AZD7503 subcutaneously.
DRUG	Placebo	Randomised participants will receive placebo subcutaneously.

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-03-20
• Completion: 2024-03-20
• First posted: 2023-10-23
• Last updated: 2025-07-20

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study