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Healthy volunteers test new drug AMG 378 for safety

NCT ID NCT06910709

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety and tolerability of a new drug called AMG 378 in 48 healthy adults aged 18 to 55. Participants received either the drug or a placebo, and researchers monitored for side effects and how the drug moved through the body. The study was terminated early, and it was not designed to treat any disease.

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

48 people

The number who actually took part.

Started

Apr 2025

Finished

Dec 2025

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 55 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: * Male and female participants ≥ 18 to ≤ 55 years (inclusive) at the time of signing the informed consent. * Body mass index between 18 and 30 kg/m\^2, inclusive, at screening. * Men (even with a history of vasectomy) with partners of childbearing potential must agree to practice sexual abstinence or use a male barrier method of contraception (ie, male condom with spermicide) in addition to a second method of acceptable contraception by female partner from Check-in until 30 days after the last dose of investigational product. * Participant must be overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) recording(s) at the screening and Day 1 visits. Exclusion Criteria: * History of malignancy of any type. * History of esophageal, gastric, or duodenal ulceration prior to screening visit. * Evidence of active bacterial, viral, fungal or parasitic infections within the last 30 days prior to study Day 1. * History or evidence of clinically significant arrhythmia at screening, or Day 1 ECG. * A QT interval corrected for heart rate (HR) based on the Fridericia method (QTcF) interval \> 450 ms in all participants regardless of biological sex or history/evidence of long QT syndrome at screening or study Day -1. * Positive results for human immunodeficiency virus (HIV) antibodies, HIV antigen, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus ribonucleic acid (RNA) at screening. * History of active tuberculosis (TB) infection, current symptoms concerning for active TB, or positive or indeterminate interferon gamma release assay (IGRA). * Positive test for drugs, cotinine (tobacco use) or alcohol use at screening or on Day -1. * Sexually active female participants of childbearing potential unwilling to use 2 protocol specified highly effective methods of contraception during treatment and for an additional 30 days after the last dose of investigational product. * Alcohol consumption from 48 hours prior to study Day 1. * Use of tobacco- or nicotine-containing products within 6 months prior to study Day 1.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Dr. Vince Clinical Research

    Overland Park, Kansas, 66212, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

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