Study: NCT05454462

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: IMP Application KM-001
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Chemistry
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Chemistry
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Chemistry
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Hematology
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Hematology
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Hematology
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Urinalysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Urinalysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Urinalysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Serelogy
Description: Patients will provide a blood sample for serelogy test at day -14 (screening visit)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Serelogy
Description: Patients will provide a blood sample for serelogy test at day -14 (screening visit)

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Serelogy
Description: Patients will provide a blood sample for serelogy test at day -14 (screening visit)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: 12-Lead ECG
Description: patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: 12-Lead ECG
Description: patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: 12-Lead ECG
Description: patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pregnancy test
Description: Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pregnancy test
Description: Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Pregnancy test
Description: Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Blood PK sampling
Description: PK test will be performed on day 1, 7, 28, 35 and on ET visit

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Blood PK sampling
Description: PK test will be performed on day 1, 7, 28, 35 and on ET visit

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Blood PK sampling
Description: PK test will be performed on day 1, 7, 28, 35 and on ET visit

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Physical Examination
Description: patients will undergo a physical examination on all the clinical visits

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Physical Examination
Description: patients will undergo a physical examination on all the clinical visits

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Physical Examination
Description: patients will undergo a physical examination on all the clinical visits

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Vital signa
Description: patient's vital signs will be measured on all the clinical visits

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Vital signa
Description: patient's vital signs will be measured on all the clinical visits

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Vital signa
Description: patient's vital signs will be measured on all the clinical visits

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Investigator's Global Assessment
Description: patient's disease evaluations will be evaluated on all the clinical visits