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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Medical and Analytical eXellence CMAX Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Emmaues Coordinator of this site? Confirm its status | Mechelen | Belgium | Active, not recruiting |
| Winchester District Memorial Hospital Coordinator of this site? Confirm its status | Winchester | Canada | Unknown status |
| VPD Heart and Lung Research Institute Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Chelsea And Westminster Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Medicines Evaluation Unit Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Translational Clinical Research LLC Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Brigham and Womens Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina Clinical and Translational Research Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| ClinCept, LLC Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Orange County Research Center Coordinator of this site? Confirm its status | Lake Forest | United States | Unknown status |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Allergy Asthma and Clinical Research Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Destiny Research Center Coordinator of this site? Confirm its status | Palmetto Bay | United States | Unknown status |
| North Carolina Clinical Research Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Prism Research LLC dba Nucleus Network Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Endeavor Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Mayflower Clinical Coordinator of this site? Confirm its status | South Dartmouth | United States | Unknown status |
| Chesapeake Clinical Research, Inc. Coordinator of this site? Confirm its status | White Marsh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.