A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
Study Details
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.
Protocol Summary
Part A: Number of Participants With Treatment-emergent Adverse Events
Timeframe: Day 1 through Week 36 (End of Study)
Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye
Timeframe: Baseline to End of Treatment (EoT) (approximately 6 Months)
Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732
Timeframe: Up to Week 36
Part A: Time to Cmax (Tmax) of AMG 732
Timeframe: Up to Week 36
Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732
Timeframe: Up to Week 36
Part A: Half-life (t1/2) of AMG 732
Timeframe: Up to Week 36
Part A: Number of Participants With Anti-drug Antibodies (ADAs)
Timeframe: Up to Week 36
Part B: Number of Participants With Treatment-emergent Adverse Events
Timeframe: Up to Week 48
Part B: Cmax of AMG 732
Timeframe: Up to Week 48
Part B: Tmax of AMG 732
Timeframe: Up to Week 48
Part B: AUC of AMG 732 Over the Dosing Interval
Timeframe: Up to Week 48
Part B: Accumulation of AMG 732 Following Multiple Dosing
Timeframe: Up to Week 48
Part B: Half-life (t1/2) of AMG 732
Timeframe: Up to Week 48
Part B: Number of Participants With Anti-drug Antibodies (ADAs)
Timeframe: Up to Week 48
Part B: Proptosis Response Status in the Study Eye
Timeframe: EoT (approximately 6 Months)
Part B: Mean Change from Baseline in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) Visual Functioning (VF) Subscale Score
Timeframe: Baseline to EoT (approximately 6 Months)
Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score
Timeframe: Baseline to EoT (approximately 6 Months)