A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
- Registration Number
- NCT06401044
- Lead Sponsor
- Amgen
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: AMG 732 AMG 732 Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD). Part A: Placebo Placebo Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD). Part B: AMG 732 Low Dose AMG 732 Participants will receive AMG 732 low dose SC. Part B: AMG 732 Medium Dose AMG 732 Participants will receive AMG 732 medium dose SC. Part B: AMG 732 High Dose AMG 732 Participants will receive AMG 732 high dose SC. Part B: Placebo Placebo Participants will receive placebo SC.
- Primary Outcome Measures
Name Time Method Part A: Number of Participants With Treatment-emergent Adverse Events Day 1 through Week 36 (End of Study) Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye Baseline to End of Treatment (EoT) (approximately 6 Months)
- Secondary Outcome Measures
Name Time Method Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732 Up to Week 36 Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732 Up to Week 36 Part A: Half-life (t1/2) of AMG 732 Up to Week 36 Part A: Number of Participants With Anti-drug Antibodies (ADAs) Up to Week 36 Part B: Number of Participants With Treatment-emergent Adverse Events Up to Week 48 Part B: Half-life (t1/2) of AMG 732 Up to Week 48 Part B: Number of Participants With Anti-drug Antibodies (ADAs) Up to Week 48 Part A: Time to Cmax (Tmax) of AMG 732 Up to Week 36 Part B: Cmax of AMG 732 Up to Week 48 Part B: Tmax of AMG 732 Up to Week 48 Part B: AUC of AMG 732 Over the Dosing Interval Up to Week 48 Part B: Accumulation of AMG 732 Following Multiple Dosing Up to Week 48 Part B: Proptosis Response Status in the Study Eye EoT (approximately 6 Months) Responders are defined as participants with a ≥ 2 mm reduction from baseline in the study eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
Part B: Mean Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Visual Functioning (VF) Subscale Score Baseline to EoT (approximately 6 Months) Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score Baseline to EoT (approximately 6 Months)
Trial Locations
- Locations (5)
North Shore Private Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Macquarie University Hospital
🇦🇺Sydney, New South Wales, Australia
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Ilumina Medical Research
🇺🇸Kissimmee, Florida, United States
Ppd Las Vegas Research Unit
🇺🇸Las Vegas, Nevada, United States
North Shore Private Hospital🇦🇺Saint Leonards, New South Wales, Australia