Recruitment Complete
Sponsor ID
20230302

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

Sponsor ID
20230302
Clinicaltrials.gov ID
NCT06401044
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 732
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
94
Additional Study Details

Protocol Summary

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Locations

Location
Status
Contact Us
Location
Ppd Las Vegas Research Unit
Las Vegas, NV, United States, 89113
Status
Recruiting
Location
Levenson Eye Associates
Jacksonville, FL, United States, 32204
Status
Recruiting
Location
Ilumina Medical Research
Kissimmee, FL, United States, 34744
Status
Recruiting
Location
Macquarie University
North Ryde, NSW, Australia, 2109
Status
Recruiting
Location
North Shore Private Hospital
St Leonards, NSW, Australia, 2065
Status
Recruiting
Location
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Status
Recruiting
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