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A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Sponsor: Amgen
Summary
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.
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Integrated Single Ascending Dose, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2024-10-16
Completion Date
2027-06-07
Last Updated
2026-04-09
Healthy Volunteers
Yes
Conditions
Interventions
AMG 691
Subcutaneous (SC) injection
Placebo
SC injection
Locations (21)
Orange County Research Center
Lake Forest, California, United States
Translational Clinical Research LLC
Aventura, Florida, United States
Destiny Research Center
Palmetto Bay, Florida, United States
ClinCept, LLC
Columbus, Georgia, United States
Chesapeake Clinical Research Inc
White Marsh, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Mayflower Clinical
South Dartmouth, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
University of North Carolina Clinical and Translational Research Center
Chapel Hill, North Carolina, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Monroe Biomedical Research
North Charleston, South Carolina, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, Australia
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen, Belgium
Winchester District Memorial Hospital
Winchester, Ontario, Canada
VPD Heart and Lung Research Institute
Cambridge, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
The Medicines Evaluation Unit
Manchester, United Kingdom