Healthy volunteers test new drug AMG 378 for safety
NCT ID NCT06910709
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.
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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
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48 people
The number who actually took part.
- Started
-
Apr 2025
- Finished
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Dec 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dr. Vince Clinical Research
Overland Park, Kansas, 66212, United States
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Orange County Research Center
Lake Forest, California, 92630, United States
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