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NCT06637371Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
21 (actual)
First submitted
9 Oct 2024
Start date
16 Oct 2024
Primary completion date
10 Apr 2027
Lead sponsor
Amgen
Diseases
Asthma
NCT number
NCT06637371
EU CT number
2025-520503-27-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 21
  • From 16 Oct 2024 to the primary completion date, 10 Apr 2027
  • 21 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Medical and Analytical eXellence CMAX
Coordinator of this site? Confirm its status
AdelaideAustraliaUnknown status
Emmaues
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MechelenBelgiumActive, not recruiting
Winchester District Memorial Hospital
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WinchesterCanadaUnknown status
VPD Heart and Lung Research Institute
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Chelsea And Westminster Hospital
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LondonUnited KingdomUnknown status
The Medicines Evaluation Unit
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ManchesterUnited KingdomUnknown status
Translational Clinical Research LLC
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AventuraUnited StatesUnknown status
Brigham and Womens Hospital
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BostonUnited StatesUnknown status
University of North Carolina Clinical and Translational Research Center
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Chapel HillUnited StatesUnknown status
ClinCept, LLC
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Orange County Research Center
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Lake ForestUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
Monroe Biomedical Research
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North CharlestonUnited StatesUnknown status
Allergy Asthma and Clinical Research Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Destiny Research Center
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Palmetto BayUnited StatesUnknown status
North Carolina Clinical Research
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RaleighUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Prism Research LLC dba Nucleus Network
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Saint PaulUnited StatesUnknown status
Endeavor Clinical Trials
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San AntonioUnited StatesUnknown status
Mayflower Clinical
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South DartmouthUnited StatesUnknown status
Chesapeake Clinical Research, Inc.
Coordinator of this site? Confirm its status
White MarshUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.