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Clinical Trials in the UK / NCT06637371
Active, not recruiting Phase 1

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

NCT06637371 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 1
Started
2024-10-16
Last updated
2026-06-17

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

AMG 691Placebo

AMG 691: Subcutaneous (SC) injection

Placebo: SC injection

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Part A and B * Participants must be capable of giving informed consent and have provided informed consent. * Participants must be 18 to 65, inclusive at time of signing of informed consent. * Participants must have a Body Mass Index between 18.0 to 30 kg/m\^2 and total body weight ≥ 40 kg at screening. * Participants must be overtly healthy as determined by the investigator based on medical evaluation and study screening procedures. * Female participants must be of non-childbearing potential. Inclusion Part C * Participants must be capable of giving informed consent and have provided informed consent. * Participants must be 18 to 70, inclusive at time of signing of informed consent. * Body mass index between 18.0 to 35 kg/m\^2 and total body weight ≥ 40 kg at screening. * Participants must have documentation of physician diagnosed asthma for ≥ 12 months prior to screening. * Participants must have documented bronchodilator responsiveness of forced expiratory volume in 1 second (FEV1) ≥ 10% in the 10 years before screening or at the screening visit. * Participants must have a pre-bronchodilator percent predicted FEV1 ≥ 50% at screening visit and Day -1. For participants on high-dose ICS, participants must have a percent-predicted FEV1 ≥ 70% at screening visit and on day -1. * Participants must have peripheral blood eosinophils ≥ 200 cells/μl at screening visit and Day -1. * Participants must have a fractional exhaled nitric oxide (FeNO) ≥ 25 ppb at screening visit and Day -1. * Participant must not use inhaled corticosteroids (ICS) or must be treated with low-dose, medium-dose, or high-dose ICS and on a stable dose for a minimum of 12 weeks prior to screening. Exclusion (applicable to all study parts) * History of malignancy (except for in situ cervical cancer or surgically excised non-melanoma skin cancer occurring more than 5 years prior to randomization). * History of anaphylaxis or hypersensitivity to biologic therapy or sensitivity to mammalian derived products. * History of immunodeficiency or history of severe infection within the last 3 years requiring IV antibiotics. * History of tuberculosis (TB), TB symptoms, or positive interferon gamma release assay. * History of untreated or unresolved helminthic infection within 24 weeks of day 1. * Positive human immunodeficiency virus (HIV) antibodies, hepatitis B core antigen, hepatitis B core antibody, or hepatitis C virus (HCV) ribonucleic acid (RNA). * Male participants unwilling to follow contraceptive requirements. Additional Exclusion for Part C only * Female of childbearing potential not willing to use 2 methods of contraception with one being a highly effective method of contraception. * History of pulmonary disease that may interfere with interpretation of study results. * History of upper respiratory infection within 6 weeks of screening. * Asthma Control Questionnaire (ACQ-6) \> 3. * Asthma symptoms or exacerbations requiring 2 or more systemic corticosteroid bursts (≥10 mg/day prednisone or equivalent for ≥ 3 days each) in the previous 12 months. * More than one hospitalization or emergency department visit in the last year. * History of life-threatening asthma exacerbation after the 12 years age requiring admission to intensive care unit.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Orange County Research Center Lake Forest California
Translational Clinical Research LLC Aventura Florida
Destiny Research Center Palmetto Bay Florida
ClinCept, LLC Columbus Georgia
Chesapeake Clinical Research Inc White Marsh Maryland
Brigham and Womens Hospital Boston Massachusetts
Mayflower Clinical South Dartmouth Massachusetts
Mayo Clinic Rochester Minnesota
Prism Research LLC dba Nucleus Network Saint Paul Minnesota
University of North Carolina Clinical and Translational Research Center Chapel Hill North Carolina
Monroe Biomedical Research Monroe North Carolina
North Carolina Clinical Research Raleigh North Carolina
Allergy Asthma and Clinical Research Center Oklahoma City Oklahoma
Monroe Biomedical Research North Charleston South Carolina
Endeavor Clinical Trials San Antonio Texas
Clinical Medical and Analytical eXellence CMAX Adelaide South Australia
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw Mechelen Belgium
Winchester District Memorial Hospital Winchester Ontario
VPD Heart and Lung Research Institute Cambridge United Kingdom
Chelsea and Westminster Hospital London United Kingdom
The Medicines Evaluation Unit Manchester United Kingdom

More Amgen trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06637371 on ClinicalTrials.gov ↗ ← All trials in the UK