A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease

Condition studied

Thyroid Eye Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye

Endpoint detail

Subject incidence of treatment-emergent adverse events, including serious adverse events, PK parameters including but not limited to maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), area under the concentration time curve (AUC) over the dosing interval, accumulation following multiple dosing, and if feasible, half-life (t1/2) as data permits., Subject incidence of antidrug antibodies (ADAs), Proptosis response status in the study eye 9999 proptosis in the fellow eye) at week 9999, Mean change from Baseline at Week 9999 in the GO-QoL Visual Functioning (VF) subscale score, Mean change from Baseline at Week 9999 in the GO-QoL Appearance (A) subscale score