A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Amgen
Study ID
NCT06401044
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Thyroid Eye Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • AMG 732 — DRUG
    SC injection
  • Placebo — OTHER
    SC injection

Study Details

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.

Key Dates

Start date
May 30, 2024
Status verified
May 2026
Primary completion
Feb 22, 2027
Completion
Aug 13, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Part A: Number of Participants With Treatment-emergent Adverse Events [ Time Frame: Day 1 through Week 36 (End of Study) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Applied Research Center of ArkansasLittle RockArkansas72205-
Levenson Eye AssociatesJacksonvilleFlorida32204-
Ilumina Medical ResearchKissimmeeFlorida34744-
Sarasota Retina InstituteSarasotaFlorida34239-
Vision Medical Research, Inc.Orland ParkIllinois60462-
Ppd Las Vegas Research UnitLas VegasNevada89113-
Erie Retina ResearchEriePennsylvania16505-
Consano Clinical Research, LLCShavano ParkTexas78231-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Little Rock, AR

By research site
Applied Research Center of Arkansas· Little Rock, ARLevenson Eye Associates· Jacksonville, FLIlumina Medical Research· Kissimmee, FLSarasota Retina Institute· Sarasota, FLVision Medical Research, Inc.· Orland Park, ILPpd Las Vegas Research Unit· Las Vegas, NV

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