RecruitingPhase 1NCT06637371

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

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

Sponsor

Amgen

Enrollment

124 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Asthma

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests AMG 691, a new biologic drug, to evaluate its safety, tolerability, and how the body processes it. The study involves both healthy volunteers and people with mild-to-moderate asthma — particularly those with elevated levels of eosinophils (immune cells linked to allergic inflammation). **You may be eligible if...** - You are 18–65 years old - You are a healthy adult with a normal BMI, OR you have had a physician-diagnosed asthma for at least 12 months - If you have asthma: you have elevated eosinophils (≥200 cells/μl), elevated exhaled nitric oxide (≥25 ppb), and confirmed airway response to a bronchodilator - You are not of childbearing potential (females) **You may NOT be eligible if...** - You have a history of cancer, anaphylaxis, or severe infections in the past 3 years - You have a history of tuberculosis - You have immune deficiency - You are pregnant or able to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMG 691

Subcutaneous (SC) injection

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06637371

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