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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: AMG 378; Drug: Placebo

• Registration Number: NCT06910709
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study First Posted: 2025-04-04
• Study Start: 2025-04-08
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2028-09-20
• Study Completion: 2028-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: Single Ascending Dose (SAD)	AMG 378	Participants will be randomized in a 3:1 ratio to receive a single dose of either AMG 378 or placebo.
Part A: Single Ascending Dose (SAD)	Placebo	Participants will be randomized in a 3:1 ratio to receive a single dose of either AMG 378 or placebo.
Part A: Food-effect Cohort	AMG 378	Participants will be randomized 1:1 in a cross-over design to receive a single dose of AMG 378 in each of the 2 periods. Dosing under fasting conditions will occur after a 10-hour fast. Dosing under fed conditions will be within 30 minutes of the start of a high-fat breakfast. There will be a 7-day washout between each cross-over period.
Part B: Multiple Ascending Dose (MAD)	AMG 378	Participants will be randomized in a 3:1 ratio to receive multiple doses of either AMG 378 or placebo.
Part B: Multiple Ascending Dose (MAD)	Placebo	Participants will be randomized in a 3:1 ratio to receive multiple doses of either AMG 378 or placebo.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing a Treatment-emergent Adverse Event (TEAE)	Day 1 to Day 30 (SAD/MAD) or Day 40 (food effect cohort)

Secondary Outcome Measures

Name	Time	Method
SAD/MAD Only: Maximum Observed Concentration (Cmax) of AMG 378	Day 1 to Day 30
SAD/MAD Only: Time of Cmax (Tmax) of AMG 378	Day 1 to Day 30
SAD/MAD Only: Area Under the Concentration Time Curve (AUC) of AMG 378	Day 1 to Day 30
Food Effect Cohort Only: AUC of AMG 378 in the Fed Versus Fasted State	Day 1 to Day 14
Food Effect Cohort Only: Cmax of AMG 378 in the Fed Versus Fasted State	Day 1 to Day 14

Trial Locations

Locations (1)

Orange County Research Center; 🇺🇸 Lake Forest, California, United States