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?

This trial explores the safety and tolerability of a new treatment called AMG 378. Researchers will administer either a single or multiple doses of AMG 378, or a placebo, to healthy participants to observe their body's reactions. Some participants will test the effects of taking AMG 378 after a meal. The trial seeks healthy individuals who do not smoke or use drugs and have not experienced any major illnesses or infections recently. As a Phase 1 trial, this research aims to understand how AMG 378 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that AMG 378 is likely to be safe for humans?

Research shows that AMG 378 is undergoing safety testing in healthy volunteers. In the trials so far, participants have received either the drug or a placebo, a harmless pill used for comparison. The study aims to assess how well people tolerate AMG 378. As an early-stage trial, it focuses on gathering initial safety information. Researchers closely monitor any side effects and participants' responses to the treatment. Since AMG 378 remains in the early testing phase, detailed safety results are not yet available. However, early trials like this are crucial for understanding a drug's safety before it advances to more comprehensive testing stages. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AMG 378 because it offers a fresh approach to treatment by delivering doses through both single and multiple ascending methods, which could optimize dosage effectiveness and safety profiles. Unlike typical treatments that might require longer periods to determine therapeutic levels, AMG 378's structured dosing strategy—especially the multiple ascending dose—could allow for quicker adjustments and more personalized treatment plans. Additionally, the food-effect cohort provides insights into how meal timing and content can influence the drug's absorption, potentially leading to more effective administration guidelines compared to existing treatments.

What evidence suggests that AMG 378 could be effective?

Research shows that AMG 378 is undergoing testing to determine its safety and tolerability. This trial consists of different parts: in Part A, participants receive a single ascending dose or participate in a food-effect cohort, while in Part B, they receive multiple ascending doses. Scientists are monitoring for side effects and assessing its suitability for use. Although there is limited information on its effectiveness for specific conditions, understanding its safety is a crucial first step. Early tests often emphasize this to ensure no major risks exist before exploring its potential effectiveness in treating illnesses. Currently, the focus remains on ensuring its safety for participants. ^{1 2 3 4 6}

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

Citations

1. withpower.com withpower.com/trial/amg-378-for-healthy-subjects-81821

AMG 378 for Healthy Subjects This Phase 1 medical study run by Amgen is evaluating whether AMG 378 will have tolerable side effects & efficacy for patients with Healthy Subjects.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06910709

Single and Multiple Ascending Dose Study of AMG 378 in ... 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.

3. trial.medpath.com trial.medpath.com/clinical-trial/52f4c510d4c069f2/nct06910709-amg-378-safety-pharmacokinetics-healthy

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

4. tipranks.com tipranks.com/news/company-announcements/amgens-new-clinical-study-a-potential-game-changer-for-investors

Amgen's New Clinical Study: A Potential Game Changer ... The primary purpose is to gather basic scientific data on AMG 378. The study began on March 28, 2025, with the latest update submitted on June 6 ...

5. clinconnect.io clinconnect.io/trials/NCT06910709

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

6. msn.com msn.com/en-us/money/savingandinvesting/amgen-s-new-clinical-study-a-potential-game-changer-for-investors/ar-AA1PiuuH

Amgen's New Clinical Study: A Potential Game Changer ... ' The study aims to assess the safety and tolerability of AMG 378, a new drug, in healthy volunteers. This research is significant as it lays the groundwork ...