MedPath

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

Phase 1
Active, not recruiting
Conditions
Thyroid Eye Disease
Interventions
Other: Placebo
Registration Number
NCT06401044
Lead Sponsor
Amgen
Brief Summary

The primary objective of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses.

Detailed Description

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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
48
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Part A: AMG 732AMG 732Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Part A: PlaceboPlaceboParticipants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Primary Outcome Measures
NameTimeMethod
Part A: Number of Participants With Treatment-emergent Adverse EventsDay 1 through Week 36 (End of Study)
Secondary Outcome Measures
NameTimeMethod
Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732Up to Week 36
Part A: Time to Cmax (Tmax) of AMG 732Up to Week 36
Part A: Half-life (t1/2) of AMG 732Up to Week 36
Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732Up to Week 36

Trial Locations

Locations (1)

Ppd Las Vegas Research Unit

🇺🇸

Las Vegas, Nevada, United States

© Copyright 2025. All Rights Reserved by MedPath