Testing AMG 378 for safety in healthy volunteers

A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose and Food-effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AMG 378 in Healthy Participants

This study tests the safety of a new drug called AMG 378 in healthy volunteers to see how it affects their bodies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Amgen (industry)
• Locations: 1 site (Lake Forest, California)
• Trial ID: NCT06910709 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of AMG 378 administered in single and multiple doses to healthy participants. It involves a thorough medical evaluation to ensure participants are in good health before receiving the investigational drug or a placebo. The study aims to gather pharmacokinetic data to understand how the drug behaves in the body. Participants will be monitored closely for any adverse effects throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 55 with a body mass index between 18 and 30.

Not a fit: Patients with a history of malignancy or significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data for AMG 378, paving the way for its use in future treatments.

How similar studies have performed: Other studies assessing the safety of new drugs in healthy volunteers have shown success, making this approach well-established.

Eligibility criteria

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.
* 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 this trial is running

Lake Forest, California

• Orange County Research Center — Lake Forest, California, United States (RECRUITING)

Study contacts

• Study coordinator: Amgen Call Center

Conditions: Healthy Volunteers, Pharmacokinetics, Healthy Volunteer