MK-8644: first-in-human test in healthy people and people with psoriasis
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
Run by Merck Sharp & Dohme LLC · NCT07850310 · Data updated 2026-11-12
This early-phase study tests MK-8644 versus placebo in healthy volunteers and people with psoriasis to see if it is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Status | Recruiting |
| Started | October 20, 2026 |
| Main results expected | December 13, 2027 |
| Study ends | December 13, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07850310 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in good health or adults with psoriasis who have a BMI between 18 and 36 kg/m^2 and meet all inclusion criteria without disqualifying health conditions.
✕Probably not a fit
Participants with significant autoimmune, cardiovascular, hepatic, renal, or infectious diseases, or with certain cancers or uncontrolled illnesses may not benefit and could be exposed to risks without advantage.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, first-in-human trial evaluating MK-8644 in healthy participants and individuals with psoriasis. Participants will receive MK-8644 or a placebo to assess safety, tolerability, and preliminary dosing biomarkers. The study aims to identify any adverse effects and determine how well participants can tolerate the medication. The trial is sponsored by Merck Sharp & Dohme LLC and conducted at a site in Melbourne, Australia. Enrollment is limited to adults meeting specific health and BMI criteria, with several medical history exclusions to ensure participant safety.
Why it matters
Potential benefit: If successful, the study could establish a safe dose range for MK-8644 and inform future research on its potential benefits for conditions related to psoriasis.
How similar studies have gone: Early human trials for MK-8644 or similar compounds have not yet established safety in this context, making this a novel first-in-human evaluation with uncertain outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Where it's running
-
Nucleus Network ( Site 0001)
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@merck.com
- Phone: 1-888-577-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.