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

CK Regeon

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CKR-051 Dose 1; Drug: CKR-051 Dose 3; Drug: CKR-051 Dose 2; Drug: CKR-051 Dose 4; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05833906

COSMOS-21-RegenT-1

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: Male

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

CKR-051 SAD

Experimental group

Description:

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.

Treatment:

Drug: CKR-051 Dose 4

Drug: CKR-051 Dose 2

Drug: Placebo

Drug: CKR-051 Dose 3

Drug: CKR-051 Dose 1

CKR-051 MAD

Experimental group

Description:

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.

Treatment:

Drug: CKR-051 Dose 4

Drug: CKR-051 Dose 2

Drug: Placebo

Drug: CKR-051 Dose 3