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New treatment option for Olmsted Syndrome
Official title Study of KM-023 in Healthy Volunteers and Patients With Olmsted Syndrome.
ClinicalTrials.gov ID: NCT07090889
What this study is testing
What is KM-023?
KM-023 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for olmsted syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Part A
- Healthy female and male participants.
- Female participants of non-childbearing potential, childbearing potential and males capable of fathering a child must meet the contraception...
- Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 1 month prior to screening visit.
- Not using prescription medication 14 days prior to admission; and 7 days prior to admission for over the counter (OTC)...
You likely can't join if
- Part A
- Participants who are staff members at the investigational site directly involved in conducting the study.
- Evidence or history of clinically relevant hepatic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic...
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of screening.
- Screening supine BP ≥145 mm Hg (systolic) or ≥90 mm Hg (diastolic)
- Participants with any abnormalities in clinical laboratory tests, and serology results, at screening, considered by the study physician as clinically...
See the full eligibility criteria
Who can join
- Part A
- Healthy female and male participants.
- Female participants of non-childbearing potential, childbearing potential and males capable of fathering a child must meet the contraception requirements.
- Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 1 month prior to screening visit.
- Not using prescription medication 14 days prior to admission; and 7 days prior to admission for over the counter (OTC) medication/vitamins/supplements.
- Must not be taking any medication that could potentially impair hepatic or renal function at the time of screening.
- No history of alcohol or other drugs of abuse.
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 (inclusive); and a total body weight \>50.0 kg (110 lbs) and \<100.0 kg (220 lbs) at screening and Day -1.
- No vaccines given within 14 days of dosing.
- Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research. Part B
- Read, understood, and signed an ICF before any investigational procedure(s) are performed.
- Clinical diagnosis of OS, with confirmed TRPV3 or PERP mutation, and visible palmoplantar keratoderma.
- Stable medical condition over the previous 1 month.
- Willingness and ability to comply with the treatment and follow-up visits.
- Willingness to refrain from current treatments, in compliance with the list of prohibited medications.
- No contraindications to study medication as determined by the Investigator.
- Female participants of non-childbearing potential, childbearing potential and males capable of fathering a child must meet the contraception requirements.
- Negative serum pregnancy test at screening, and negative urinary pregnancy test at Day -1.
What rules you out
- Part A
- Participants who are staff members at the investigational site directly involved in conducting the study.
- Evidence or history of clinically relevant hepatic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of screening.
- Screening supine BP ≥145 mm Hg (systolic) or ≥90 mm Hg (diastolic)
- Participants with any abnormalities in clinical laboratory tests, and serology results, at screening, considered by the study physician as clinically significant.
- Pregnant or breastfeeding female participants.
- Participants who donated blood or received blood or plasma derivatives in the 30 days preceding study drug administration.
- Dosed in another clinical trial within at least 10 tissue half-lives prior to dosing or 4 months.
- Known relevant allergy to any drug or excipients in the formulation
- Participants with any acute medical situation (e.g., acute infection) within 48h of screening or start of dosing, which is considered of significance by the Investigator.
- Major surgery within the last 3 months or any planned surgery during the trial.
- Unwilling or unable to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures and the restrictions described in the protocol.
- Any other condition or previous therapy that, in the opinion of the Investigator or their designee, would render the participant unsuitable for this study, including an inability to fully comply with the study protocol...
- The presence of other significant dermatological conditions that could interfere with the evaluation of the study treatment's safety and how well it works.
- Active or uncontrolled infections (e.g., sepsis, tuberculosis, hepatitis B or hepatitis C at the screening visit, human immunodeficiency virus[HIV]) that could complicate participation in the study.
- Any medical or active psychological condition or any clinically relevant laboratory abnormalities, such as, but not limited, to elevated ALT or AST (\> 3 × ULN) in combination with elevated bilirubin (\> 2 × ULN), at...
- Diabetic foot ulcers.
- Patient is unwilling to refrain from using prohibited medications during the clinical trial.
- Currently participating or participated in any other clinical trial of an IMP or device, within the past 4 months before the screening visit.
- Cutaneous infection or another underlying condition of the skin which may impact the assessments or trial participants.
- Cutaneous infection of the area to be treated with IMP within 2 weeks before the screening visit or any infection of treatment area requiring treatment with oral, parenteral antibiotics, antivirals, antiparasitics or...
- Pregnant or breastfeeding patient.
- Having received any of the prohibited treatments in Table 2 within the specified timeframe before inclusion.
- Known relevant allergy to any drug or excipients in the formulation.
- Major surgery within the last 3 months, or minor surgery (requiring local anesthetic) during last 1 month, or any planned surgery during the trial.
- Unwilling or unable to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures and the restrictions described in the protocol.
- Any other condition or previous therapy that, in the opinion of the Investigator or their designee, would render the patient unsuitable for this study, including an inability to fully comply with the study protocol...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Paris, France
- Rennes, France
- London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Paris, France; Rennes, France; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.