Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Orvida Pharma (formerly Kamari Pharma)
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 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.
You may not be 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, 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 requirements or a likelihood of noncompliance with study procedures.
Part B
The presence of other significant dermatological conditions that could interfere with the evaluation of the study treatment's safety and efficacy.
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 the screening/baseline visit.
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 antifungals or any topical within 2 weeks before the screening visit.
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 requirements or a likelihood of noncompliance with study procedures.
Clareo Health | Study of KM-023 in Healthy Volunteers and Patients With Olmsted Syndrome.
