PsoriasisPhase 1NCT07850310
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
A Phase 1 study testing MK-8644 in people with Psoriasis and Healthy, run by Merck Sharp & Dohme LLC at 1 site in Australia.
Trial summary
The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people. This trial will help researchers learn about the safety of MK-8644 and if participants tolerate it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- MK-8644
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Oct 2026to 13 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a BMI between 18 and 36 kg/m^2, inclusive
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has a history of cancer.
- Has a history of significant multiple and/or severe allergies.
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, tuberculosis, or HIV.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network ( Site 0001)
Melbourne, Victoria, 3004
Study Coordinator, +61 3 8593 9801
About this study
Official title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses, Food Effect, and Relative Bioavailability of MK-8644 in Healthy Japanese and Non-Japanese Participants and Multiple Doses of MK-8644 in Patients With Mild to Moderate Plaque Psoriasis
The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people.
This trial will help researchers learn about the safety of MK-8644 and if participants tolerate it. Tolerate means participants will receive MK-8644 in the trial unless they need to stop it due to health problems.
- Being tested
- MK-8644, Placebo for MK-8644
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8644Drug
Oral administration
Placebo for MK-8644Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| MK-8644 | Experimental | Participants receive MK-8644 orally under fasted or fed conditions depending on randomization. Receives: Drug: MK-8644 |
| Placebo | Placebo comparator | Participants receive matching placebo for MK-8644 orally under fasted or fed conditions depending on randomization. Receives: Drug: Placebo for MK-8644 |
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
Measured: Up to approximately 43 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 approximately 28 days
Secondary outcomes (5)
Plasma Concentration at 24 Hours (C24) of MK-8644
Blood samples will be collected at designated timepoints to determine the C24 of MK-8644
Measured: At designated timepoints up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of MK-8644
Blood samples will be collected at designated timepoints to determine the Cmax of MK-8644
Measured: Predose and at designated timepoints up to 4 days post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-8644
Blood samples will be collected at designated timepoints to determine the Tmax of MK-8644
Measured: Predose and at designated timepoints up to 4 days post-dose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-8644
Blood samples will be collected at designated timepoints to determine the AUC0-Last of MK-8644
Measured: Predose and at designated timepoints up to 4 days post-dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-8644
Blood samples will be collected at designated timepoints to determine the AUC0-Inf of MK-8644
Measured: Predose and at designated timepoints up to 4 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 posted30 Sep 2026
- Study start20 Oct 2026
- Primary completion13 Dec 2027 (estimated)
- Study completion13 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
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
- NCT07850310
- Sponsor's protocol ID
- 8644-001
- Other IDs
- MK-8644
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses, Food Effect, and Relative Bioavailability of MK-8644 in Healthy Japanese and Non-Japanese Participants and Multiple Doses of MK-8644 in Patients With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07850310
- Acronym / sponsor ID
- 8644-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 13 Dec 2027 (estimated)
- Study completion
- 13 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (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 this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people.
This trial will help researchers learn about the safety of MK-8644 and if participants tolerate it. Tolerate means participants will receive MK-8644 in the trial unless they need to stop it due to health problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-8644 | Experimental | Drug: MK-8644Participants receive MK-8644 orally under fasted or fed conditions depending on randomization. |
| Placebo | Placebo comparator | Drug: Placebo for MK-8644Participants receive matching placebo for MK-8644 orally under fasted or fed conditions depending on randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is in good health
- Has a BMI between 18 and 36 kg/m^2, inclusive
Key exclusion criteria (5 listed)
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has a history of cancer.
- Has a history of significant multiple and/or severe allergies.
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, tuberculosis, or HIV.
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-8644Oral administration | Drug | MK-8644 |
| Placebo for MK-8644Oral administration | Drug | Placebo |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 43 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 approximately 28 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
5 secondary outcomes
Plasma Concentration at 24 Hours (C24) of MK-8644
Time frame: At designated timepoints up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of MK-8644
Time frame: Predose and at designated timepoints up to 4 days post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-8644
Time frame: Predose and at designated timepoints up to 4 days post-dose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-8644
Time frame: Predose and at designated timepoints up to 4 days post-dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-8644
Time frame: Predose and at designated timepoints up to 4 days post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Our Company's Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
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-8644 in people with Psoriasis and Healthy, run by Merck Sharp & Dohme LLC at 1 site in Australia.
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 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@merck.com), or a site near the patient. 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 43 days). 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 27 Oct 2026.