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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2026-10-16

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The food-effect cohort will have a cross-over design with 2 periods.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Single Ascending Dose (SAD)

Participants will be randomized in a 3:1 ratio to receive a single dose of either AMG 378 or placebo.

Group Type EXPERIMENTAL

AMG 378

Intervention Type DRUG

Oral tablet

Placebo

Intervention Type DRUG

Oral tablet

Part A: Food-effect Cohort

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.

Group Type EXPERIMENTAL

AMG 378

Intervention Type DRUG

Oral tablet

Part B: Multiple Ascending Dose (MAD)

Participants will be randomized in a 3:1 ratio to receive multiple doses of either AMG 378 or placebo.

Group Type EXPERIMENTAL

AMG 378

Intervention Type DRUG

Oral tablet

Placebo

Intervention Type DRUG

Oral tablet

Interventions

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AMG 378

Oral tablet

Intervention Type DRUG

Placebo

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes