Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.

Key facts

Study ID

NCT06910709

Run by

Amgen

People needed

48

Starts

2025-04-08

Expected to finish

2025-12-02

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orange County Research Center — Lake Forest, California, United States
• Dr. Vince Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.