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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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/m\^2, inclusive, at screening.

• The participant has adequate venous access and can receive intravenous (IV) therapy.

• The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.

• Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic Japanese who were born in Japan; Hold a Japanese passport or identity papers; Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan.

• Male or female aged 18 to 65 years.

• Moderate-to-severe active TED.

• The participant had onset of active TED within 15 months prior to baseline.

• Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline.

• Proptosis ≥18mm in the study eye at baseline.

• Participants with baseline subjective binocular diplopia score \>0.

• Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.

Locations
United States
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
Florida
Levenson Eye Associates
RECRUITING
Jacksonville
Ilumina Medical Research
RECRUITING
Kissimmee
Sarasota Retina Institute
RECRUITING
Sarasota
Illinois
Vision Medical Research, Inc.
RECRUITING
Orland Park
Nevada
Ppd Las Vegas Research Unit
RECRUITING
Las Vegas
Pennsylvania
Erie Retina Research
RECRUITING
Erie
Texas
Consano Clinical Research, LLC
RECRUITING
Shavano Park
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
Australia
Macquarie University
RECRUITING
North Ryde
North Shore Private Hospital
RECRUITING
St Leonards
France
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
RECRUITING
Nantes
Hopital Pitie-Salpetriere
RECRUITING
Paris
Poland
Eb Group Spolka z ograniczona odpowiedzialnoscia
RECRUITING
Warsaw
Spain
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2027-08-13
Participants
Target number of participants: 88
Treatments
Experimental: Part A: AMG 732
Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Placebo_comparator: Part A: Placebo
Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Experimental: Part B: AMG 732 Low Dose
Participants will receive AMG 732 low dose SC.
Experimental: Part B: AMG 732 Medium Dose
Participants will receive AMG 732 medium dose SC.
Experimental: Part B: AMG 732 High Dose
Participants will receive AMG 732 high dose SC.
Placebo_comparator: Part B: Placebo
Participants will receive placebo SC.
Related Therapeutic Areas
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov

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