AMG 378 for Healthy Subjects

Recruiting at 1 trial location

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Malignancy, Ulceration, Infections, Arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18 to 55 with a BMI of 18-30. Participants must be in good health as confirmed by medical exams, tests, and ECGs. Men with partners who can have children must use contraception from check-in until 30 days after the last dose.

Inclusion Criteria

My BMI is between 18 and 30.

I am generally healthy as confirmed by a medical exam and tests.

I agree to use two forms of contraception if my partner can have children.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single dose of AMG 378 or placebo

1 week

1 visit (in-person)

Food-effect Cohort

Participants receive a single dose of AMG 378 under fasting and fed conditions with a 7-day washout period

2 weeks

2 visits (in-person)

Multiple Ascending Dose (MAD)

Participants receive multiple doses of AMG 378 or placebo

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMG 378

Trial Overview The study is testing AMG 378 given either once or multiple times against a placebo to see how safe it is and how well people tolerate it. The participants will not know if they are receiving the real drug or a placebo.

How Is the Trial Designed?

Group I: Part B: Multiple Ascending Dose (MAD) Experimental Treatment 2 Interventions

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

Group II: Part A: Single Ascending Dose (SAD) Experimental Treatment 2 Interventions

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

Group III: Part A: Food-effect Cohort Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London