HealthyPhase 1NCT06821334
A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)
A Phase 1 study testing MK-6194 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
Trial summary
The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-6194
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2024to 9 Aug 2024
- 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
- The key inclusion criteria include but are not limited to the following:
- Is in good health
- Has body mass index (BMI) within 18.0 to 28.0 kg/m^2 (inclusive) and weight ≥50 kg
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of opportunistic infection, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital (Site 0001)
Beijing, Beijing Municipality, 100191
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics of MK-6194 in Healthy Chinese Participants
The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.
- Conditions
- Healthy
- Being tested
- MK-6194, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6194Biological
Subcutaneous Administration
PlaceboBiological
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Panel A | Experimental | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo. Receives: Biological: MK-6194; Biological: Placebo |
| Panel B | Experimental | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo. Receives: Biological: MK-6194; Biological: Placebo |
| Panel C | Experimental | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo. Receives: Biological: MK-6194; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to 42 days post dose
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to 42 days post dose
Secondary outcomes (8)
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of MK-6194
Blood samples will be collected at specified intervals to determine the AUC0-last of MK-6194.
Measured: Up to 42 days post dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
Blood samples will be collected at specified intervals to determine the AUC0-inf of MK-6194.
Measured: Up to 42 days post dose
Maximum Serum Concentration (Cmax) of MK-6194
Blood samples will be collected at specified intervals to determine the Cmax of MK-6194.
Measured: Up to 42 days post dose
Time to Maximum Serum Concentration (Tmax) of MK-6194
Blood samples will be collected at specified intervals to determine the Tmax of MK-6194.
Measured: Up to 42 days post dose
Apparent Terminal Half-life (t1/2) of MK-6194
Blood samples will be collected at specified intervals to determine the t1/2 of MK-6194.
Measured: Up to 42 days post dose
Apparent Clearance (CL/F) of MK-6194
Blood samples will be collected at specified intervals to determine the CL/F of MK-6194.
Measured: Up to 42 days post dose
Apparent Volume of Distribution during terminal phase (Vz/F) of MK-6194
Blood samples will be collected at specified intervals to determine the Vz/F of MK-6194.
Measured: Up to 42 days post dose
Incidence of Antidrug Antibodies (ADA) to MK-6194
Blood samples will be collected at specified intervals to determine the ADA response to MK-6194.
Measured: Up to 42 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start23 Apr 2024
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821334
- Sponsor's protocol ID
- 6194-014
- Other IDs
- MK-6194-014
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics of MK-6194 in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT06821334
- Acronym / sponsor ID
- 6194-014
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 12 Feb 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 goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel A | Experimental | Biological: MK-6194, Biological: PlaceboParticipants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo. |
| Panel B | Experimental | Biological: MK-6194, Biological: PlaceboParticipants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo. |
| Panel C | Experimental | Biological: MK-6194, Biological: PlaceboParticipants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has body mass index (BMI) within 18.0 to 28.0 kg/m^2 (inclusive) and weight ≥50 kg
Key exclusion criteria (3 listed)
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of opportunistic infection, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis
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 |
|---|---|---|
| MK-6194Subcutaneous Administration | Biological | Panel A, Panel B, Panel C |
| PlaceboSubcutaneous administration | Biological | Panel A, Panel B, Panel C |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 42 days post dose
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to 42 days post dose
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
8 secondary outcomes
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of MK-6194
Time frame: Up to 42 days post dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
Time frame: Up to 42 days post dose
Maximum Serum Concentration (Cmax) of MK-6194
Time frame: Up to 42 days post dose
Time to Maximum Serum Concentration (Tmax) of MK-6194
Time frame: Up to 42 days post dose
Apparent Terminal Half-life (t1/2) of MK-6194
Time frame: Up to 42 days post dose
Apparent Clearance (CL/F) of MK-6194
Time frame: Up to 42 days post dose
Apparent Volume of Distribution during terminal phase (Vz/F) of MK-6194
Time frame: Up to 42 days post dose
Incidence of Antidrug Antibodies (ADA) to MK-6194
Time frame: Up to 42 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-6194 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Who Experience an Adverse Event (AE) (time frame: Up to 42 days post dose). The study lists 2 primary outcomes in all. 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 12 Feb 2025.