NCT05885451

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects

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

Summary

The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.

Conditions

• Chronic Graft-versus-Host Disease (cGVHD)

Interventions

Type	Name	Description
DRUG	AMG 592	Administered as SC injection
OTHER	Placebo	Administered as SC injection

Timeline

• Start date: 2019-01-29
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study