Status:
RECRUITING
Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants
Lead Sponsor:
Amgen
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- 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
- 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.
- Sexually active 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.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06910709
Start Date
April 8 2025
End Date
October 16 2026
Last Update
January 8 2026
Active Locations (2)
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1
Orange County Research Center
Lake Forest, California, United States, 92630
2
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212