NCT06401044

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Detailed description

Recruitment has ended for the Phase 1 portion of the study and will reopen when Phase 2 begins recruitment.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	AMG 732	SC injection
OTHER	Placebo	SC injection

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-02-22
• Completion: 2027-08-13
• First posted: 2024-05-06
• Last updated: 2026-04-09

Locations

30 sites across 11 countries: United States, Australia, Canada, France, Germany, Italy, Japan, Poland, Singapore, Spain, Taiwan

Regulatory

• FDA-regulated drug study