RECRUITING

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

Conditions

Healthy Volunteers Pharmacokinetics Healthy Volunteer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose and Food-effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AMG 378 in Healthy Participants

Quick Facts

Study Start:2025-04-08

Study Completion:2028-09-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06910709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Amgen Call Center

CONTACT

866-572-6436

medinfo@amgen.com

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

Orange County Research Center

Lake Forest, California, 92630

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-08

Study Completion Date2028-09-20

Study Record Updates

Study Start Date2025-04-08

Study Completion Date2028-09-20

Terms related to this study

Keywords Provided by Researchers

Pharmacokinetics
Healthy Volunteer

Additional Relevant MeSH Terms

Healthy Volunteers