Healthy ParticipantsPhase 1NCT07745907
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
A Phase 1 study testing AMG 691 in people with Healthy Participants, run by Amgen at 1 site in United States.
Trial summary
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AMG 691
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2026to 31 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants, 18 to 60 years of age.
- First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents).
- Body mass index (BMI) 18.0 to 30.0 kg/m^2 (inclusive) and body weight ≥40 kg.
- In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Female participants must not be pregnant or breastfeeding.
- Participants of reproductive potential must agree to follow protocol-specified contraception requirements.
- Willing to maintain usual diet and physical activity regimen throughout study participation.
Who cannot join
- Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results.
- Clinically significant ECG abnormalities
- Clinically significant abnormal blood pressure or pulse rate at screening/check-in.
- History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer >5 years before dosing).
- Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in.
- History of hypersensitivity/anaphylaxis to biologic therapies, mammalian-derived products, or AMG 691 excipients.
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- Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years.
- Positive or indeterminate QuantiFERON-TB Gold test.
- Untreated or unresolved helminth parasitic infection.
- History of immunodeficiency.
- Receipt of live or live-attenuated vaccines within 12 weeks before check-in or planned during the study.
- Estimated glomerular filtration rate (eGFR) <70 mL/min/1.73 m^2.
- Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin >1.5 × Upper Limit Normal (ULN).
- Positive screening tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection. Hepatitis B serology consistent with prior vaccination is permitted.
- Use of prohibited prescription, over-the-counter, herbal, vitamin, or dietary supplement products within 30 days (or 5 half-lives) before enrollment, unless approved by the investigator.
- History of illicit drug use within 1 year, positive drug screen, or unwillingness to abstain from illicit drugs/cannabinoids during the study.
- Use of tobacco or nicotine-containing products within 6 months prior to check-in.
- History of alcohol abuse or excessive alcohol consumption.
- History of non-suicidal self-injury within 5 years or unstable major depressive disorder/other severe psychiatric disorder within 2 years.
- Participation in another investigational drug study within 90 days (or 5 half-lives) prior to check-in.
- Previous exposure to AMG 691.
- Recent donation of blood, plasma, or platelets.
- Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PPD - Las Vegas Research Unit
Las Vegas, Nevada, 89113
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
- Conditions
- Healthy Participants
- Being tested
- AMG 691
- Keywords
- AMG 691, Respiratory Tract Diseases, Asthma, Lung Diseases
- Medical subject headings
- Respiratory Tract Diseases, Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 691Drug
AMG 691 will be administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC) Receives: Drug: AMG 691 |
| Cohort 2 | Experimental | Japanese participants will receive AMG 691 at the Level A dose administered SC Receives: Drug: AMG 691 |
| Cohort 3 | Experimental | Chinese participants will receive AMG 691 at the Level B dose administered SC Receives: Drug: AMG 691 |
| Cohort 4 | Experimental | Japanese participants will receive AMG 691 at the Level B dose administered SC Receives: Drug: AMG 691 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax) of AMG 691
Measured: Day 1 up to Day 154
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of AMG 691
Measured: Up to Day 154
Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691
Measured: Up to Day 154
Secondary outcomes (3)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 to end of trial (approximately 154 days)
Number of Participants with Serious Adverse Events (SAEs)
Measured: From screening (Day -28) up to end of trial (approximately 154 days)
Number of Participants Who Develop Anti-AMG 691 Antibodies
Measured: Up to Day 154
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start7 Aug 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
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
- NCT07745907
- Sponsor's protocol ID
- 20240037
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants
- ClinicalTrials.gov ID
- NCT07745907
- Acronym / sponsor ID
- 20240037
- Conditions
- Healthy Participants
- Keywords
- AMG 691, Respiratory Tract Diseases, Asthma, Lung Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Aug 2026 (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 trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AMG 691Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC) |
| Cohort 2 | Experimental | Drug: AMG 691Japanese participants will receive AMG 691 at the Level A dose administered SC |
| Cohort 3 | Experimental | Drug: AMG 691Chinese participants will receive AMG 691 at the Level B dose administered SC |
| Cohort 4 | Experimental | Drug: AMG 691Japanese participants will receive AMG 691 at the Level B dose administered SC |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female participants, 18 to 60 years of age.
- First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents).
- Body mass index (BMI) 18.0 to 30.0 kg/m^2 (inclusive) and body weight ≥40 kg.
- In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Female participants must not be pregnant or breastfeeding.
Key exclusion criteria (23 listed)
- Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results.
- Clinically significant ECG abnormalities
- Clinically significant abnormal blood pressure or pulse rate at screening/check-in.
- History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer >5 years before dosing).
- Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in.
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 691AMG 691 will be administered subcutaneously | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Maximum Observed Serum Concentration (Cmax) of AMG 691
Time frame: Day 1 up to Day 154
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of AMG 691
Time frame: Up to Day 154
Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691
Time frame: Up to Day 154
3 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to end of trial (approximately 154 days)
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From screening (Day -28) up to end of trial (approximately 154 days)
Number of Participants Who Develop Anti-AMG 691 Antibodies
Time frame: Up to Day 154
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 28 Oct 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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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.
MD study director
Amgen
1 site in 1 country: 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 Healthy Participants, run by Amgen at 1 site in United States.
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 7 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Serum Concentration (Cmax) of AMG 691 (time frame: Day 1 up to Day 154). The study lists 3 primary outcomes in all. 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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.