A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

Part of paid clinical trials in Lake Forest, California.

Sponsor
Amgen
Study ID
NCT06637371
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • AMG 691 — DRUG
    Subcutaneous (SC) injection
  • Placebo — DRUG
    SC injection

Study Details

The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy participants and participants with mild-to-moderate asthma.

Key Dates

Start date
Oct 16, 2024
Status verified
Apr 2026
Primary completion
Jun 7, 2027
Completion
Jun 7, 2027

Study Design

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

Arms

  • Experimental: Part A: Single Ascending Dose (SAD)
    Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
  • Experimental: Part B: Multiple Ascending Dose (MAD)
    Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
  • Experimental: Part C: Multiple Dose
    Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.

Primary Outcome Measure

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 11 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Orange County Research CenterLake ForestCalifornia92630-
Translational Clinical Research LLCAventuraFlorida33180-
Destiny Research CenterPalmetto BayFlorida33157-
ClinCept, LLCColumbusGeorgia31904-
Chesapeake Clinical Research IncWhite MarshMaryland21162-
Brigham and Womens HospitalBostonMassachusetts02115-
Mayflower ClinicalSouth DartmouthMassachusetts02747-
Mayo ClinicRochesterMinnesota55905-
Prism Research LLC dba Nucleus NetworkSaint PaulMinnesota55114-
University of North Carolina Clinical and Translational Research CenterChapel HillNorth Carolina27599-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
North Carolina Clinical ResearchRaleighNorth Carolina27607-
Allergy Asthma and Clinical Research CenterOklahoma CityOklahoma73120-
Monroe Biomedical ResearchNorth CharlestonSouth Carolina29406-
Endeavor Clinical TrialsSan AntonioTexas78240-

Find similar trials in Lake Forest, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Orange County Research Center· Lake Forest, CATranslational Clinical Research LLC· Aventura, FLDestiny Research Center· Palmetto Bay, FLClinCept, LLC· Columbus, GAChesapeake Clinical Research Inc· White Marsh, MDBrigham and Womens Hospital· Boston, MA

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