55
Participants
Start Date
May 24, 2022
Primary Completion Date
April 4, 2023
Study Completion Date
April 4, 2023
IMP Application KM-001
KM-001 will be supplied in glass jars (30 ml) and will be provided to patients with spatulas and polyethylene gloves on all the clinical visits. the patient will use IMP twice a day for 28 days.
Chemistry
patients will provide a blood sample for a chemistry blood test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.
Hematology
patients will provide a blood sample for a hematology blood test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.
Urinalysis
Patients will provide a blood sample for a urine test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.
Serelogy
Patients will provide a blood sample for serelogy test at day -14 (screening visit)
12-Lead ECG
patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).
Pregnancy test
Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested
Blood PK sampling
PK test will be performed on day 1, 7, 28, 35 and on ET visit
Physical Examination
patients will undergo a physical examination on all the clinical visits
Vital signa
patient's vital signs will be measured on all the clinical visits
Investigator's Global Assessment
patient's disease evaluations will be evaluated on all the clinical visits
Itch Assessment via PP-NRSj
patient's disease evaluations will be evaluated on all the clinical visits
E-diary data
The patient will record IMP adminidsration and AE events in a diary every day throughout the all study period
Rothhaar Studien GmbH, Berlin
Fachklinik Bad Bentheim - Dermatologische Studienambulanz, Bensheim
Lead Sponsor
Collaborators (1)
Bioskin GmbH
INDUSTRY
Kamari Pharma Ltd
NETWORK