This is a phase 1, multi-center, randomized, vehicle-controlled, double-blinded, parallel-group study. Approximately 6 sites will conduct the study at Germany. Approximately 61 patients (male and female) planned to be screened. 51 patient planned to be randomized. Patients will be randomized to 1 of 3 treatment arms (KM-001 0.3%, KM-001 1%, or vehicle cream) iina a ration of 1:1:1 Patient's duration of participation will be up to 7 weeks, * a screening period with 1 visit (Visit 1) within up to 14 days (Days -14 to -1), * a 4-week treatment period with 3 visits (Visit 2 on Day 0, Visit 3 on Day 7, Visit 4 at Day 28 and 2 phone calls on Days 14 and 21, and * a 1-week follow-up period with 1 visit (Visit 5 on Day 35), as well as unscheduled visits as needed Since KM-001 is tested in humans for the first time, the safety of KM-001 will be evaluated in a subgroup of 6 patients (sentinel group) at selected sites prior to screening of the remaining sites. Efficacy assessments will include subjective assessments of itch and investigator assessment of the treatment effect on LSC target lesion using scoring systems. Safety parameter (including physical examination, vital signs, ECG, standard laboratory test, and PK analysis) will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit. Recording of AEs and serious AEs (SAEs) will be done throughout the study with special attention to local AEs in the treatment area (LSC target lesion, dermal safety).
Age range
18 Years – 75 Years
Sex
ALL
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Safety endpoint - Will be assessed through collection and analysis of adverse events
Timeframe: up to 7 weeks
Safety endpoint-Hematology blood test
Timeframe: up to 7 weeks
Safety endpoint- Serology blood test - HBV
Timeframe: up to 14 days
Safety endpoint- Serology blood test- Hepatits C
Timeframe: up to 14 days
Safety endpoint- Serology blood test- HIV
Timeframe: up to 14 days
Safety endpoint-Chemistry
Timeframe: up to 7 weeks
Safety endpoin-Urine tests
Timeframe: up to 7 weeks
Safety endpoin-Pregnancy test
Timeframe: up to 7 weeks
Safety endpoin-Vital signs- Pulse
Timeframe: up to 7 weeks
Safety endpoin-Vital signs- Blood pressure
Timeframe: up to 7 weeks
Safety endpoin-Vital signs- Body temperature
Timeframe: up to 7 weeks
Safety endpoin-Electrocardiogram
Timeframe: up to 7 weeks
Safety endpoin-Physical examination
Timeframe: up to 4 weeks
KM-001 plasma levels (PK) - Cmax
Timeframe: Up to 5 weeks
KM-001 plasma levels (PK) - Tmax
Timeframe: Up to 5 weeks
KM-001 plasma levels (PK) - AUC 0-t
Timeframe: Up to 5 weeks