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

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AMG 378; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06910709

20230274

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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92 participants in 3 patient groups

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: AMG 378

Part A: Food-effect Cohort

Experimental group

Description:

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.

Treatment:

Drug: AMG 378

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: AMG 378