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Could a single injection of AMG 691 be safe and Well-Tolerated?

NCT ID NCT07745907

Knowledge-focused Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 1 trial is testing a single dose of the investigational drug AMG 691 in healthy Chinese and Japanese adults aged 18 to 60. The goal is to understand how the drug moves through the body and to check its safety and tolerability. Participants will receive one subcutaneous injection and be monitored for side effects and immune responses. The results will help guide future studies of AMG 691.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AMG 691
What this could lead to
If successful, this early study could support further development of AMG 691 as a potential treatment for various conditions, though its intended use is not yet disclosed.
What could go wrong
This is a small, early-phase trial in healthy volunteers, so results may not predict effects in patients. Safety and tolerability are still unknown, and the drug may not proceed to later stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • PPD - Las Vegas Research Unit

    RECRUITING

    Las Vegas, Nevada, 89113, United States

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