Actively Recruiting
Study of KM-023 in Healthy Volunteers and Patients With Olmsted Syndrome.
Led by Kamari Pharma Ltd · Updated on 2025-07-29
64
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial is conducted in order to assess the safety of KM-023 and to observe what effects, both beneficial and adverse, it has on the body, and the way the body absorbs and eliminates KM-023, first in healthy participants, then in Olmsted Syndrome patients. In addition, the study will examine the presence of KM-023 in the different layers of the skin. Finally, the efficacy of KM-023 will be investigated in Olmsted Syndrome patients. The first part of this trial will be conducted with healthy participants in France, then after its completion, the second part of the trial will be conducted with Olmsted Syndrome patients in France and the United Kingdom. The first part of the trial is itself divided in two parts: first, a series of single doses will be given to groups of healthy participants, then other groups of healthy participants will be given repeated doses of KM-023 twice daily for 5 days. The participants will be hospitalized approximately 2 days for the investigation of single doses, and approximately 8 days for the investigation of the multiple doses. Some participants will receive the KM-023, and other will receive a placebo, which is a non-active product. Four (4) different dose levels will be given in the trial part studying single administration, and 3 different dose levels in the trial part studying repeated administrations. The trial will start with the lowest doses, and the dose levels will be gradually increased after the safety and tolerability of the previous dose level has been assessed by a group of experts (including physicians). In order to assess the safety, a series of examinations will be conducted, including taking blood samples. Blood samples will also be collected a regular timepoints in order to evaluate the changes in concentration of KM-023 in blood over time. One group of participants will receive a single dose of KM-023 twice: once after fasting, and once with a meal, to check any effect of food on the concentration of KM-023 in blood. In the second part of the trial, Olmsted Syndrome patients will take KM-023 twice daily, for a duration of 12 weeks. There will be a first hospitalization day, during which the patients will receive the study drug, and will be taught how to self-administer KM-023 at home during the ambulatory periods. Safety and efficacy tests will be performed, and the concentration of KM-023 in blood will be monitored. Patients will then go back home with their treatment, to be taken every day. After the first hospitalization day, there will be five visits (two of them will be 1-day hospitalization periods), to monitor the safety and tolerability, the efficacy, and the concentration of KM-023 in blood. Between the hospitalization visits, the clinical teams will call the patients at home on a regular basis to check the safety and tolerability. The duration of participation, including the selection period and the follow-up period, is a maximum 36 days when only one dose is given, 51 days when the dose is given on two occasions to assess the effect of food, 40 days when treatment is given twice daily for 5 days, and 18 weeks in the case of Olmsted Syndrome patients.
CONDITIONS
Official Title
Study of KM-023 in Healthy Volunteers and Patients With Olmsted Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy female and male participants aged 18 to 55 years for Part A
- Female participants of childbearing or non-childbearing potential and males capable of fathering a child must meet contraception requirements
- Non-smoking and no tobacco or nicotine product use for at least 1 month before screening
- No prescription medication use 14 days prior to admission; no OTC medication, vitamins, or supplements 7 days prior
- No medications impairing liver or kidney function at screening
- No history of alcohol or drug abuse
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, weight between 50.0 kg and 100.0 kg
- No vaccines within 14 days of dosing
- Covered by a health insurance system as applicable
- For Part B, clinical diagnosis of Olmsted Syndrome with confirmed TRPV3 or PERP mutation and visible palmoplantar keratoderma
- Stable medical condition over past month
- Willingness and ability to comply with treatment and follow-up visits
- Willingness to refrain from prohibited treatments
- No contraindications to study medication as determined by Investigator
- Negative pregnancy tests at screening and Day -1 for females of childbearing potential
You will not qualify if you...
- Staff members involved in the study at investigational sites
- History or evidence of clinically relevant diseases affecting major organs or systems
- Regular alcohol consumption exceeding limits within 6 months before screening
- High blood pressure at screening (systolic 25145 mm Hg or diastolic 2590 mm Hg)
- Clinically significant abnormal lab or serology results at screening
- Pregnant or breastfeeding females
- Blood donation or receipt of blood products within 30 days before dosing
- Participation in another clinical trial within 10 tissue half-lives or 4 months
- Known allergy to study drug or its components
- Acute medical conditions within 48 hours before screening or dosing
- Major surgery within 3 months or planned surgery during the trial
- Inability or unwillingness to comply with study visits, treatment, or protocol restrictions
- Other conditions or therapies that could interfere with participation or compliance
- For Part B, presence of other significant skin conditions, active infections (e.g., sepsis, tuberculosis, hepatitis B or C, HIV)
- Elevated liver enzymes combined with elevated bilirubin at screening
- Diabetic foot ulcers
- Use of prohibited medications or treatments as defined by the protocol
- Cutaneous infections affecting the treatment area within 2 weeks before screening
- Recent minor surgery requiring local anesthesia within 1 month before trial
- Any other condition deemed unsuitable by Investigator or designee
AI-Screening
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Trial Site Locations
Total: 1 location
1
Biotrial
Rennes, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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