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Monoclonal Antibodies

AMG 732 for Thyroid Eye Disease

Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active liver disease or hepatic dysfunction at screening, as determined by ALT (alanine aminotransferase) or aspartate aminotransferase (AST) levels > 1.5 times upper limit of normal (ULN).
Male or female aged 18 to 55 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial aims to understand if AMG 732 is safe and well-tolerated when given as a single injection under the skin."

Who is the study for?
This trial is for healthy adults aged 18-55 with a BMI of 18-30, and women must be unable to bear children. Participants should have good health as confirmed by various medical assessments. It's also open to healthy Japanese individuals who meet specific heritage criteria but haven't lived outside Japan for more than 10 years.
What is being tested?
The study is testing the safety and tolerability of a single subcutaneous dose of AMG 732 in people without any health issues and those with Thyroid Eye Disease, comparing it against a placebo.
What are the potential side effects?
Since this is an investigation into AMG 732's safety, potential side effects are being studied; however, common reactions may include irritation at the injection site, allergic reactions or systemic side effects that will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is not functioning properly, with high ALT or AST levels.
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I am between 18 and 55 years old.
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I am a woman who cannot become pregnant.
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I can receive treatments through an IV.
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I haven't had cancer in the past year, except for certain skin or cervical cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Part A: AMG 732Experimental Treatment1 Intervention
Participants in 5 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Group II: Part A: PlaceboPlacebo Group1 Intervention
Participants in 5 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,910 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,825 Total Patients Enrolled
~27 spots leftby Jun 2027