NCT05955183

Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..

Phase-1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Oral Doses in Japanese and Chinese Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD5055 after single and multiple doses, orally administered in healthy Japanese and Chinese participants.

Detailed description

The study will be conducted in 2 parts: 1. Part 1 in single ascending dose (SAD) 2. Multiple dose Eligible Japanese and Chinese participants will be randomized to receive oral dose of either AZD5055 or placebo. The study will comprise of: * A Screening Period of maximum 28 days. * A Treatment Period during which participants will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration until at least 72 hours after IMP administration. * A Follow-up Visit within 7 ± 1 (for Part 1) and 15 ± 1 (for Part 2) days after the last IMP dose. For the SAD part of the study, each participant will be involved in the study for 5 to 6 weeks. For the multiple dose part of the study, each participant will be involved in the study for 7 to 8 weeks.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5055	AZD5055 will be given orally to randomized participants as per the arm they are assigned.
DRUG	Placebo	Placebo will be given orally to randomized participants as per the arm they are assigned.

Timeline

• Start date: 2023-07-27
• Primary completion: 2023-12-04
• Completion: 2023-12-04
• First posted: 2023-07-21
• Last updated: 2023-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study