Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 691 in Healthy Adults and Adults With Mild-to-Moderate Asthma
Led by Amgen · Updated on 2026-04-09
124
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AMG 691, a drug given by subcutaneous injection, in a Phase 1 clinical trial to assess its safety and tolerability in healthy adults and adults with mild-to-moderate asthma. The study compares single and multiple doses of AMG 691 to placebo. It involves healthy participants and participants with asthma to better understand how the drug behaves in the body and its effects. The trial is randomized and double-blind, with healthy participants assigned in a 3:1 ratio to receive AMG 691 or placebo and asthma participants assigned in a 2:1 ratio. The study has different parts including single ascending dose, multiple ascending dose, and multiple dose periods. Each participant receives subcutaneous injections of either AMG 691 or placebo according to their group assignment. Participants will undergo medical evaluations, including lung function tests and blood tests, to monitor safety and drug effects over approximately 11 months. Researchers will track treatment-emergent adverse events and measure drug concentration in the blood. The study includes follow-up visits to assess safety and tolerability over time, ensuring comprehensive monitoring of participants throughout the trial.
CONDITIONS
Brief Title
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 to 65 years old (Parts A and B) or 18 to 70 years old (Part C) at the time of consent.
- Participants must be able to give informed consent.
- Body mass index must be 18.0 to 30 kg/m² and weight at least 40 kg for Parts A and B; BMI 18.0 to 35 kg/m² and weight at least 40 kg for Part C.
- Participants must be overtly healthy for Parts A and B.
- Female participants in Parts A and B must be of non-childbearing potential.
- Participants in Part C must have a physician diagnosis of asthma for at least 12 months.
- Participants in Part C must have documented bronchodilator responsiveness (FEV1 increase ≥10%) within 10 years or at screening.
- Participants in Part C must have pre-bronchodilator percent predicted FEV1 ≥50% (≥70% if on high-dose inhaled corticosteroids) at screening and Day -1.
- Participants in Part C must have peripheral blood eosinophils ≥200 cells/μl at screening and Day -1.
- Participants in Part C must have fractional exhaled nitric oxide (FeNO) ≥25 ppb at screening and Day -1.
- Participants in Part C must be either not using inhaled corticosteroids or on a stable dose of low, medium, or high-dose inhaled corticosteroids for at least 12 weeks prior to screening.
You will not qualify if you...
- History of malignancy except in situ cervical cancer or excised non-melanoma skin cancer over 5 years prior.
- History of anaphylaxis or hypersensitivity to biologic therapy or mammalian derived products.
- History of immunodeficiency or severe infection requiring IV antibiotics in last 3 years.
- History or symptoms of tuberculosis or positive TB test.
- Untreated or unresolved helminthic infection within 24 weeks before day 1.
- Positive for HIV antibodies, hepatitis B core antigen or antibody, or hepatitis C RNA.
- Male participants unwilling to follow contraceptive requirements.
- For Part C only: Female of childbearing potential not willing to use two contraception methods including one highly effective method.
- History of pulmonary disease interfering with study results.
- Upper respiratory infection within 6 weeks prior to screening.
- Asthma Control Questionnaire (ACQ-6) score greater than 3.
- Two or more systemic corticosteroid bursts in past 12 months.
- More than one hospitalization or emergency visit in past year.
- Life-threatening asthma exacerbation requiring ICU admission after age 12.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 11 months
Participants receive subcutaneous injections of AMG 691 or placebo as part of different dosing regimens depending on the study part.
Visits scheduled according to dosing regimens in Parts A, B, and C
Trial Site Locations
Total: 21 locations
1
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
2
Translational Clinical Research LLC
Aventura, Florida, United States, 33180
Actively Recruiting
3
Destiny Research Center
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
4
ClinCept, LLC
Columbus, Georgia, United States, 31904
Completed
5
Chesapeake Clinical Research Inc
White Marsh, Maryland, United States, 21162
Actively Recruiting
6
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Mayflower Clinical
South Dartmouth, Massachusetts, United States, 02747
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States, 55114
Actively Recruiting
10
University of North Carolina Clinical and Translational Research Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
12
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Actively Recruiting
13
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
14
Monroe Biomedical Research
North Charleston, South Carolina, United States, 29406
Actively Recruiting
15
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Terminated
16
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, Australia, 5000
Actively Recruiting
17
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen, Belgium, 2800
Actively Recruiting
18
Winchester District Memorial Hospital
Winchester, Ontario, Canada, K0C 2K0
Actively Recruiting
19
VPD Heart and Lung Research Institute
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
20
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Actively Recruiting
21
The Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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