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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma (NCT06637371) is a Phase 1 interventional studying Asthma, sponsored by Amgen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Asthma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 124 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Part A and B - Participants must be capable of giving willing to sign a consent form and have provided willing to sign a consent form. - Participants must be 18 to 65, inclusive at time of signing of willing to sign a consent form. - 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 willing to sign a consent form and have provided willing to sign a consent form. - Participants must be 18 to 70, inclusive at time of signing of willing to sign a consent form. - 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

AMG 691

Subcutaneous (SC) injection

DRUG

Placebo

SC injection

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06637371), the sponsor (Amgen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06637371 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06637371?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06637371?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06637371. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06637371. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.