Clinical trial NCT06910709: Single and Multiple Ascending Dose Study of AMG 378 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Healthy Volunteer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The food-effect cohort will have a cross-over design with 2 periods.
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to Day 30 (SAD/MAD) or Day 40 (food effect cohort)
Secondary outcomes:
measure: SAD/MAD Only: Maximum Observed Concentration (Cmax) of AMG 378
timeFrame: Day 1 to Day 30
measure: SAD/MAD Only: Time of Cmax (Tmax) of AMG 378
timeFrame: Day 1 to Day 30
measure: SAD/MAD Only: Area Under the Concentration Time Curve (AUC) of AMG 378
timeFrame: Day 1 to Day 30
measure: Food Effect Cohort Only: AUC of AMG 378 in the Fed Versus Fasted State
timeFrame: Day 1 to Day 14
measure: Food Effect Cohort Only: Cmax of AMG 378 in the Fed Versus Fasted State
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Overland Park
country: United States
facility: Dr. Vince Clinical Research
state: Kansas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: