HealthyPhase 1NCT06843993
Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)
A Phase 1 study testing MK-2060 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
Trial summary
The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-2060
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 27 Oct 2023
- 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 20 to 60 years
- Men only
- 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 before randomization
- Has a body mass index (BMI) ≥18 and ≤28 kg/m^2.
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a 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 cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001)
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single-Ascending Dose Clinical Trial to Study the Safety, Pharmacokinetics and Pharmacodynamics of MK-2060 in Healthy Chinese Male Adult Participants
The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.
- Conditions
- Healthy
- Being tested
- MK-2060, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2060Biological
Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.
PlaceboBiological
Single doses of placebo administered via IV infusion on Day 1 according to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Panel A: MK-2060 Dose 1 | Experimental | MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1. Receives: Biological: MK-2060 |
| Panel B: MK-2060 Dose 2 | Experimental | MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B. Receives: Biological: MK-2060 |
| Panel C: MK-2060 Dose 3 | Experimental | MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C. Receives: Biological: MK-2060 |
| Placebo | Placebo comparator | Placebo was administered as a single IV infusion over MK-2060-matched time period on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 164 days
Number of participants who discontinue study due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 164 days
Number of participants who experience one or more AEs related to bleeding
A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major bleeding or major bleeding.
Measured: Up to 164 days
Secondary outcomes (12)
Plasma concentration at end of infusion (Ceoi) of MK-2060
Ceoi is defined as the amount of MK-2060 in plasma following IV infusion administration of MK-2060. Blood samples were collected at pre-specified time points to assess Ceoi.
Measured: Predose Day 1 and end of infusion
Plasma concentration at 168 hours (C168hr) of MK-2060
C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. Blood samples were collected at pre-specified time points to assess C168hr.
Measured: At designated timepoints (up to 168 hours)
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060
AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. Blood samples were collected at pre-specified time points to assess AUC0-inf.
Measured: At designated timepoints (up to 150 days)
AUC from 0 to 168 hours (AUC0-168) of MK-2060
AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. Blood samples were collected at pre-specified time points to assess AUC0-168.
Measured: At designated timepoints (up to 168 hours)
Time to maximum observed plasma drug concentration (Tmax) of MK-2060
Tmax is defined as time to the maximum concentration of MK-2060 reached. Blood samples were collected at pre-specified time points to assess Tmax.
Measured: At designated timepoints (up to 150 days)
Terminal half-life of MK-2060
t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. Blood samples were collected at pre-specified time points to assess terminal half-life.
Measured: At designated timepoints (up to 150 days)
Clearance (CL) of MK-2060
CL is the volume of plasma from which MK-2060 is completely removed per unit time. Blood samples were collected at pre-specified time points to assess CL.
Measured: At designated timepoints (up to 150 days)
Volume of distribution (Vz) of MK-2060
Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz.
Measured: At designated timepoints (up to 150 days)
Change from baseline in activated partial thromboplastin time (aPTT)
Blood samples were collected at pre-specified time points to assess change from baseline in aPTT.
Measured: Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)
Anti-drug antibodies (ADA) positive incidence
Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies.
Measured: At designated timepoints (up to 150 days)
Factor XI (FXI) activity level
Blood samples were collected at pre-specified time points to assess FXI activity level.
Measured: At designated timepoints (up to 150 days)
Prothrombin time (PT)
Blood samples were collected at pre-specified time points to assess PT.
Measured: At designated timepoints (up to 150 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
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
- 36 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
- NCT06843993
- Sponsor's protocol ID
- 2060-009
- Other IDs
- MK-2060-009
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Ascending Dose Clinical Trial to Study the Safety, Pharmacokinetics and Pharmacodynamics of MK-2060 in Healthy Chinese Male Adult Participants
- ClinicalTrials.gov ID
- NCT06843993
- Acronym / sponsor ID
- 2060-009
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 25 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 the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel A: MK-2060 Dose 1 | Experimental | Biological: MK-2060MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1. |
| Panel B: MK-2060 Dose 2 | Experimental | Biological: MK-2060MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B. |
| Panel C: MK-2060 Dose 3 | Experimental | Biological: MK-2060MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo was administered as a single IV infusion over MK-2060-matched time period on Day 1. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤28 kg/m^2.
Key exclusion criteria (3 listed)
- Has a 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 cancer (malignancy)
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-2060Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization. | Biological | Panel A: MK-2060 Dose 1, Panel B: MK-2060 Dose 2, Panel C: MK-2060 Dose 3 |
| PlaceboSingle doses of placebo administered via IV infusion on Day 1 according to randomization. | Biological | Placebo |
Primary outcome
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to 164 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study due to an AE
Time frame: Up to 164 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who experience one or more AEs related to bleeding
Time frame: Up to 164 days
A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major bleeding or major bleeding.
12 secondary outcomes
Plasma concentration at end of infusion (Ceoi) of MK-2060
Time frame: Predose Day 1 and end of infusion
Plasma concentration at 168 hours (C168hr) of MK-2060
Time frame: At designated timepoints (up to 168 hours)
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060
Time frame: At designated timepoints (up to 150 days)
AUC from 0 to 168 hours (AUC0-168) of MK-2060
Time frame: At designated timepoints (up to 168 hours)
Time to maximum observed plasma drug concentration (Tmax) of MK-2060
Time frame: At designated timepoints (up to 150 days)
Terminal half-life of MK-2060
Time frame: At designated timepoints (up to 150 days)
Clearance (CL) of MK-2060
Time frame: At designated timepoints (up to 150 days)
Volume of distribution (Vz) of MK-2060
Time frame: At designated timepoints (up to 150 days)
Change from baseline in activated partial thromboplastin time (aPTT)
Time frame: Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)
Anti-drug antibodies (ADA) positive incidence
Time frame: At designated timepoints (up to 150 days)
Factor XI (FXI) activity level
Time frame: At designated timepoints (up to 150 days)
Prothrombin time (PT)
Time frame: At designated timepoints (up to 150 days)
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 25 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-2060 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 25 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. Some participants in this study may receive a placebo. 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 one or more adverse events (AEs) (time frame: Up to 164 days). The study lists 3 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 25 Feb 2025.