Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of CKR-051 in healthy participants. This study aiming to develop an agent for skin regeneration; potential treatments include acute and chronic wounds (c.f. Diabetic foot ulcers).

Official Title
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A Randomized, Single-blind, Placebo-controlled, Single/Multiple Dose, Dose Escalation, Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of CKR-051 After Transdermal Administration in Healthy Male Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: CKR-051 Dose 1
* Drug: CKR-051 Dose 2
* Drug: CKR-051 Dose 3
* Drug: CKR-051 Dose 4
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age 19 years to 60 years (Healthy male) Body weight 55 kg to 90 kg and BMI 19 kg/m^2 to 29 kg/m^2 Do not have skin disease or skin damage (including scars or tattoos) or excessive body hair at the drug application site Must be suitable by a subject by medical evaluation including physical examination, laboratory tests, questionnaire, etc. Key Exclusion Criteria: History of clinically significant hepatobiliary, kidney, nervous, immune, respiratory, digestive, endocrine, blood/tumor, cardiovascular, urinary, mental, dermatological diseases, etc. With tattoos, dermatitis, pigmentation, dermatitis, etc., or damaged skin at the site of clinical trial drug administration Drug hypersensitivity reactions and history (Aspirin, antibiotics, etc.) History of drug abuse and positive urine screening test eGFR (CKD-EPI) < 60 mL/min/1.73m^2 AST/ALT > 1.5 UNL Alcohol > 21 units/week Smoker Eating food containing a grapefruit Caffeine > 5 units/day

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKR-051 SAD<br>Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. | Drug: CKR-051 Dose 1<br>* Subjects will be administered 5 g of CKR-051.<br>Drug: CKR-051 Dose 2<br>* Subjects will be administered 10 g of CKR-051.<br>Drug: CKR-051 Dose 3<br>* Subjects will be administered 10 g of CKR-051.<br>Drug: CKR-051 Dose 4<br>* Subjects will be administered 10 g of CKR-051.<br>Drug: Placebo<br>* Placebo comparator.<br>|
| Experimental: CKR-051 MAD<br>Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day. | Drug: CKR-051 Dose 2<br>* Subjects will be administered 10 g of CKR-051.<br>Drug: CKR-051 Dose 3<br>* Subjects will be administered 10 g of CKR-051.<br>Drug: CKR-051 Dose 4<br>* Subjects will be administered 10 g of CKR-051.<br>Drug: Placebo<br>* Placebo comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAD : Safety and tolerability (Numeric pain rating scale) | Score 0 to 7. Higher scores mean a worse outcome. 0 (No irritation); 1 (Minimal erythema); 2 (Erythema and papule); 3 (Palpable erythema and papule); 4 (Palpable edema); 5 (Edema, erythema and papule); 6 (Vesicular eruption); 7 (Spreading beyond the test area). | Day 1 | 
| MAD : Safety and tolerability (Numeric pain rating scale) | Score 0 to 7. Higher scores mean a worse outcome. 0 (No irritation); 1 (Minimal erythema); 2 (Erythema and papule); 3 (Palpable erythema and papule); 4 (Palpable edema); 5 (Edema, erythema and papule); 6 (Vesicular eruption); 7 (Spreading beyond the test area). | Day 1 to Day 21 (Everyday) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAD : Pharmacokinetics (Cmax) | Assessment of the peak plasma concentration of CKR-051 | Day 1 | 
| SAD : Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CKR-051 | Day 1 | 
| SAD : Pharmacokinetics (Tmax) | Assessment of the time to Cmax of CKR-051 | Day 1 | 
| SAD : Pharmacokinetics (t1/2) | Assessment of the total elimination half life of CKR-051 | Day 1 | 
| SAD : Pharmacokinetics (Vz/F) | Assessment of the volume of distribution of CKR-051 | Day 1 | 
| SAD : Pharmacokinetics (CL/F) | Assessment of the clearance of CKR-051 | Day 1 | 
| MAD : Pharmacokinetics (Cmax) | Assessment of the peak plasma concentration of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 | 
| MAD : Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 | 
| MAD : Pharmacokinetics (Tmax) | Assessment of the time to Cmax of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 | 
| MAD : Pharmacokinetics (t1/2) | Assessment of the total elimination half life of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 | 
| MAD : Pharmacokinetics (Vz/F) | Assessment of the volume of distribution of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 | 
| MAD : Pharmacokinetics (CL/F) | Assessment of the clearance of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |