Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Led by Amgen · Updated on 2026-04-09
124
Participants Needed
21
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 capable of giving informed consent and have provided informed consent.
- Participants must be 18 to 65 years old for Parts A and B, or 18 to 70 years old for Part C, inclusive at the time of consent.
- Participants must have a Body Mass Index (BMI) between 18.0 to 30 kg/m² and total body weight ≥ 40 kg for Parts A and B, or BMI between 18.0 to 35 kg/m² and total body weight ≥ 40 kg for Part C.
- Participants must be overtly healthy for Parts A and B as determined by medical evaluation and screening.
- Female participants in Parts A and B must be of non-childbearing potential.
- Participants in Part C must have documented physician-diagnosed asthma for at least 12 months prior to screening.
- Participants in Part C must have bronchodilator responsiveness of forced expiratory volume in 1 second (FEV1) ≥ 10% within the past 10 years or at screening.
- Participants in Part C must have a pre-bronchodilator percent predicted FEV1 ≥ 50%, or ≥ 70% if on high-dose inhaled corticosteroids (ICS), 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 not use ICS or be on a stable dose of low-, medium-, or high-dose ICS 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 ago.
- History of anaphylaxis or hypersensitivity to biologic therapy or mammalian-derived products.
- History of immunodeficiency or severe infection requiring IV antibiotics within the last 3 years.
- History of tuberculosis, TB symptoms, or positive interferon gamma release assay.
- History of untreated or unresolved helminthic infection within 24 weeks before Day 1.
- Positive HIV antibodies, hepatitis B core antigen or antibody, or hepatitis C virus RNA.
- Male participants unwilling to follow contraceptive requirements.
- For Part C only: female participants of childbearing potential unwilling to use two methods of contraception, including one highly effective method.
- History of pulmonary disease interfering with study results.
- Upper respiratory infection within 6 weeks of screening.
- Asthma Control Questionnaire (ACQ-6) score greater than 3.
- Asthma symptoms or exacerbations requiring two or more courses of systemic corticosteroids in the past 12 months.
- More than one hospitalization or emergency visit for asthma in the last year.
- History of life-threatening asthma requiring ICU admission after age 12.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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