Systemic SclerosisPhase 1NCT06643390
A Study of MK-2225 in Healthy Participants (MK-2225-003)
A Phase 1 study testing MK-2225 in people with Systemic Sclerosis, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial summary
The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- MK-2225
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2023to 14 Jul 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
- The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Body Mass Index (BMI) ≤32 kg/m^2, inclusive
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
- History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami (Site 0002)
Miami, Florida, 33014-3616
Bio-Kinetic Clinical Applications, LLC dba QPS-MO (Site 0004)
Springfield, Missouri, 65802
About this study
Official title: A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-2225 in Healthy Participants
The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.
- Conditions
- Systemic Sclerosis
- Being tested
- MK-2225, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2225Drug
Subcutaneous administration
PlaceboOther
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| MK-2225 Panel A | Experimental | Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks. Receives: Drug: MK-2225 |
| MK-2225 Panel B | Experimental | Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. Receives: Drug: MK-2225 |
| MK-2225 Panel C | Experimental | Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. Receives: Drug: MK-2225 |
| MK-2225 Panel D | Experimental | Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. Receives: Drug: MK-2225 |
| Placebo | Placebo comparator | Participants receive placebo SQ Q2W over the MK-2225-matched time period. Receives: Other: 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 clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 20 weeks
Number of Participants Who Discontinue Study Treatment 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. The number of participants who discontinue study/study treatment due to an AE will be reported.
Measured: Up to approximately 8 weeks
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax) of MK-2225
Blood samples will be collected to determine the Cmax of MK-2225.
Measured: At designated timepoints (up to approximately 16 weeks)
Lowest Plasma Concentration (Ctrough) of MK-2225
Blood samples will be collected to determine the Ctrough of MK-2225.
Measured: At designated timepoints (up to approximately 16 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-2225
Blood samples will be collected to determine the Tmax of MK-2225.
Measured: At designated timepoints (up to approximately 16 weeks)
Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225
Blood samples will be collected to determine the AUC0-τ of MK-2225.
Measured: At designated timepoints (up to 16 approximately weeks)
Apparent Terminal Half-life (t1/2) of MK-2225
Blood samples will be collected to determine the t1/2 of MK-2225.
Measured: At designated timepoints (up to approximately 16 weeks)
Mean Accumulation Ratio of MK-2225
Blood samples will be collected at designated timepoints to determine the mean accumulation ratio of MK-2225.
Measured: At designated timepoints (up to approximately 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start21 Nov 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT06643390
- Sponsor's protocol ID
- 2225-003
- Other IDs
- MK-2225-003
- Status last verified
- Jul 2025
- First submitted
- 14 Oct 2024
- Last updated
- 29 Jul 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-2225 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06643390
- Acronym / sponsor ID
- 2225-003
- Conditions
- Systemic Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 16 Oct 2024 (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 purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MK-2225 Panel A | Experimental | Drug: MK-2225Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks. |
| MK-2225 Panel B | Experimental | Drug: MK-2225Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. |
| MK-2225 Panel C | Experimental | Drug: MK-2225Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. |
| MK-2225 Panel D | Experimental | Drug: MK-2225Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo SQ Q2W over the MK-2225-matched time period. |
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 before randomization
- Body Mass Index (BMI) ≤32 kg/m^2, inclusive
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
- History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)
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-2225Subcutaneous administration | Drug | MK-2225 Panel A, MK-2225 Panel B, MK-2225 Panel C, MK-2225 Panel D |
| PlaceboSubcutaneous administration | Other | Placebo |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 20 weeks
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. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 8 weeks
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. The number of participants who discontinue study/study treatment due to an AE will be reported.
6 secondary outcomes
Maximum Plasma Concentration (Cmax) of MK-2225
Time frame: At designated timepoints (up to approximately 16 weeks)
Lowest Plasma Concentration (Ctrough) of MK-2225
Time frame: At designated timepoints (up to approximately 16 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-2225
Time frame: At designated timepoints (up to approximately 16 weeks)
Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225
Time frame: At designated timepoints (up to 16 approximately weeks)
Apparent Terminal Half-life (t1/2) of MK-2225
Time frame: At designated timepoints (up to approximately 16 weeks)
Mean Accumulation Ratio of MK-2225
Time frame: At designated timepoints (up to approximately 16 weeks)
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 29 Jul 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Systemic Sclerosis
Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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
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 MK-2225 in people with Systemic Sclerosis, run by Merck Sharp & Dohme LLC 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 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 29 Jul 2025. 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. 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 an Adverse Event (AE) (time frame: Up to approximately 20 weeks). 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 29 Jul 2025.