Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New asthma drug candidate enters first human safety tests

NCT ID NCT06637371

Symptom relief Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called AMG 691 in 21 healthy volunteers and people with mild-to-moderate asthma. The main goal is to see if the drug is safe and how the body processes it. Participants receive either the drug or a placebo as an injection under the skin. This study does not aim to treat asthma but to gather essential safety data before larger trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AMG 691 (an experimental drug given as an injection under the skin)
What this could lead to
If this early study shows the drug is safe, it could lead to larger trials testing whether AMG 691 helps control asthma symptoms.
What could go wrong
This is a very small, early-phase trial focused on safety, not on whether the drug works for asthma. Many drugs that appear safe in Phase 1 fail in later stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Asthma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Algemeen Ziekenhuis Sint Maarten-Emmaus vzw

    Mechelen, 2800, Belgium

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120, United States

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • Chelsea and Westminster Hospital

    London, SW10 9NH, United Kingdom

  • Chesapeake Clinical Research Inc

    White Marsh, Maryland, 21162, United States

  • ClinCept, LLC

    Columbus, Georgia, 31904, United States

  • Clinical Medical and Analytical eXellence CMAX

    Adelaide, South Australia, 5000, Australia

  • Destiny Research Center

    Palmetto Bay, Florida, 33157, United States

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240, United States

  • Mayflower Clinical

    South Dartmouth, Massachusetts, 02747, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Monroe Biomedical Research

    North Charleston, South Carolina, 29406, United States

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Prism Research LLC dba Nucleus Network

    Saint Paul, Minnesota, 55114, United States

  • The Medicines Evaluation Unit

    Manchester, M23 9QZ, United Kingdom

  • Translational Clinical Research LLC

    Aventura, Florida, 33180, United States

  • University of North Carolina Clinical and Translational Research Center

    Chapel Hill, North Carolina, 27599, United States

  • VPD Heart and Lung Research Institute

    Cambridge, CB2 0AY, United Kingdom

  • Winchester District Memorial Hospital

    Winchester, Ontario, K0C 2K0, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.