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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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • AMG 732

    Drug

    SC injection

  • Placebo

    Other intervention

    SC injection

Treatment groups

88 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: AMG 732Experimental treatment 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: AMG 732 Low DoseExperimental treatment 1 intervention
Group D: Part B: AMG 732 Medium DoseExperimental treatment 1 intervention
Group E: Part B: AMG 732 High DoseExperimental treatment 1 intervention
Group F: Part B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Number of Participants With Treatment-emergent Adverse Events

Time frame
Day 1 through Week 36 (End of Study)
2

Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye

Time frame
Baseline to End of Treatment (EoT) (approximately 6 Months)

Secondary outcomes

1

Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732

Time frame
Up to Week 36
2

Part A: Time to Cmax (Tmax) of AMG 732

Time frame
Up to Week 36
3

Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732

Time frame
Up to Week 36
4

Part A: Half-life (t1/2) of AMG 732

Time frame
Up to Week 36

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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