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Evaluating AMG 691 in healthy individuals and those 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

PHASE1 · Amgen · NCT06637371

This study is testing a new asthma treatment called AMG 691 to see if it's safe and well-tolerated in both healthy people and those with mild-to-moderate asthma.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAmgen (industry)
Drugs / interventionsprednisone
Locations21 sites (Lake Forest, California and 20 other locations)
Trial IDNCT06637371 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of AMG 691, a potential treatment for asthma, through a randomized, double-blind, placebo-controlled design. Participants will include both healthy individuals and those diagnosed with mild-to-moderate asthma, who will receive either the investigational drug or a placebo. The study will evaluate single and multiple doses of AMG 691 to determine its effects on participants' health. The primary focus is on understanding how well the drug is tolerated and its safety profile in these populations.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 65 and individuals with mild-to-moderate asthma who meet specific health criteria.

Not a fit: Patients with severe asthma or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with asthma, improving their management of the condition.

How similar studies have performed: Other studies evaluating similar approaches in asthma treatment have shown promise, but the specific use of AMG 691 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Lake Forest, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Asthma, AMG 691, Pulmonology, Immunology

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.