AsthmaPhase 1NCT06637371
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 study testing AMG 691 in people with Asthma, run by Amgen at 21 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AMG 691
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 16 Oct 2024to 10 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Participants must be capable of giving informed consent and have provided informed consent.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States15 sites
Translational Clinical Research LLC
Aventura, Florida, 33180
Brigham and Womens Hospital
Boston, Massachusetts, 02115
University of North Carolina Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599
ClinCept, LLC
Columbus, Georgia, 31904
Orange County Research Center
Lake Forest, California, 92630
Monroe Biomedical Research
Monroe, North Carolina, 28112
Monroe Biomedical Research
North Charleston, South Carolina, 29406
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Destiny Research Center
Palmetto Bay, Florida, 33157
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Mayo Clinic
Rochester, Minnesota, 55905
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
Endeavor Clinical Trials
San Antonio, Texas, 78240
Mayflower Clinical
South Dartmouth, Massachusetts, 02747
Chesapeake Clinical Research Inc
White Marsh, Maryland, 21162
United Kingdom3 sites
VPD Heart and Lung Research Institute
Cambridge, CB2 0AY
Chelsea and Westminster Hospital
London, SW10 9NH
The Medicines Evaluation Unit
Manchester, M23 9QZ
Australia1 site
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, 5000
Canada1 site
Winchester District Memorial Hospital
Winchester, Ontario, K0C 2K0
About this study
Official title: 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
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
- Asthma
- Being tested
- AMG 691, Placebo
- Keywords
- AMG 691, Pulmonology, Immunology
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 691Drug
Subcutaneous (SC) injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. Receives: Drug: AMG 691; Drug: Placebo |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. Receives: Drug: AMG 691; Drug: Placebo |
| Part C: Multiple Dose | Experimental | Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo. Receives: Drug: AMG 691; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meet at least 1 of the following serious criteria: Immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. Includes AEs of interest (AEOI), and AEs leading to discontinuation.
Measured: Up to approximately 11 months
Secondary outcomes (2)
Maximum Concentration (Cmax) of AMG 691
Measured: Up to approximately 11 months
Area Under the Curve (AUC) of AMG 691
Measured: Up to approximately 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start16 Oct 2024
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637371
- Sponsor's protocol ID
- 20230151
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06637371
- Acronym / sponsor ID
- 20230151
- Conditions
- Asthma
- Keywords
- AMG 691, Pulmonology, Immunology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: AMG 691, Drug: PlaceboHealthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: AMG 691, Drug: PlaceboHealthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. |
| Part C: Multiple Dose | Experimental | Drug: AMG 691, Drug: PlaceboParticipants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 691Subcutaneous (SC) injection | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD), Part C: Multiple Dose |
| PlaceboSC injection | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD), Part C: Multiple Dose |
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 11 months
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meet at least 1 of the following serious criteria: Immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. Includes AEs of interest (AEOI), and AEs leading to discontinuation.
2 secondary outcomes
Maximum Concentration (Cmax) of AMG 691
Time frame: Up to approximately 11 months
Area Under the Curve (AUC) of AMG 691
Time frame: Up to approximately 11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 691 in people with Asthma, run by Amgen at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Australia, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.