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

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.

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).

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