Healthy VolunteersPhase 1NCT06910709
Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants
A Phase 1 study testing AMG 378 in people with Healthy Volunteers, run by Amgen at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AMG 378
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2025to 2 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orange County Research Center
Lake Forest, California, 92630
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
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
The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- AMG 378, Placebo
- Keywords
- Pharmacokinetics, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 378Drug
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Participants will be randomized in a 3:1 ratio to receive a single dose of either AMG 378 or placebo. Receives: Drug: AMG 378; Drug: Placebo |
| Part A: Food-effect Cohort | Experimental | 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. Receives: Drug: AMG 378 |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Participants will be randomized in a 3:1 ratio to receive multiple doses of either AMG 378 or placebo. Receives: Drug: AMG 378; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Treatment-emergent Adverse Event (TEAE)
Measured: Day 1 to Day 30 (SAD/MAD) or Day 40 (food effect cohort)
Secondary outcomes (5)
SAD/MAD Only: Maximum Observed Concentration (Cmax) of AMG 378
Measured: Day 1 to Day 30
SAD/MAD Only: Time of Cmax (Tmax) of AMG 378
Measured: Day 1 to Day 30
SAD/MAD Only: Area Under the Concentration Time Curve (AUC) of AMG 378
Measured: Day 1 to Day 30
Food Effect Cohort Only: AUC of AMG 378 in the Fed Versus Fasted State
Measured: Day 1 to Day 14
Food Effect Cohort Only: Cmax of AMG 378 in the Fed Versus Fasted State
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start8 Apr 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The food-effect cohort will have a cross-over design with 2 periods.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910709
- Sponsor's protocol ID
- 20230274
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06910709
- Acronym / sponsor ID
- 20230274
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The food-effect cohort will have a cross-over design with 2 periods.
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: AMG 378, Drug: PlaceboParticipants will be randomized in a 3:1 ratio to receive a single dose of either AMG 378 or placebo. |
| Part A: Food-effect Cohort | Experimental | Drug: AMG 378Participants 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. |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: AMG 378, Drug: PlaceboParticipants will be randomized in a 3:1 ratio to receive multiple doses of either AMG 378 or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 378Oral tablet | Drug | Part A: Food-effect Cohort, Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD) |
| PlaceboOral tablet | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD) |
Primary outcome
Number of Participants Experiencing a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 30 (SAD/MAD) or Day 40 (food effect cohort)
5 secondary outcomes
SAD/MAD Only: Maximum Observed Concentration (Cmax) of AMG 378
Time frame: Day 1 to Day 30
SAD/MAD Only: Time of Cmax (Tmax) of AMG 378
Time frame: Day 1 to Day 30
SAD/MAD Only: Area Under the Concentration Time Curve (AUC) of AMG 378
Time frame: Day 1 to Day 30
Food Effect Cohort Only: AUC of AMG 378 in the Fed Versus Fasted State
Time frame: Day 1 to Day 14
Food Effect Cohort Only: Cmax of AMG 378 in the Fed Versus Fasted State
Time frame: Day 1 to Day 14
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 378 in people with Healthy Volunteers, run by Amgen at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing a Treatment-emergent Adverse Event (TEAE) (time frame: Day 1 to Day 30 (SAD/MAD) or Day 40 (food effect cohort)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.