A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
ConditionThyroid Eye Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAmgen
About this trial
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.
Eligibility criteria
Qualifiers
Participant has provided informed consent before initiation of any study-specific activities/procedures.
Male or female aged 18 to 55 years (Part A).
Female participants must be of non-childbearing potential.
Body mass index (BMI) between 18 and 30 kg/m², inclusive, at screening.
Disqualifiers
Malignant condition in the past 12 months or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.
Active liver or kidney disfunction at screening.
Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening.
Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening.
Trial design
Treatments tested in this trial
- AMG 732
- Placebo
Treatment groups
88 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov