Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects
- Conditions
- Healthy
- Interventions
- Drug: CKR-051 Dose 1Drug: CKR-051 Dose 2Drug: CKR-051 Dose 3Drug: CKR-051 Dose 4Drug: Placebo
- Registration Number
- NCT05833906
- Lead Sponsor
- CK Regeon Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKR-051 SAD CKR-051 Dose 1 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. CKR-051 SAD CKR-051 Dose 2 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. CKR-051 SAD CKR-051 Dose 3 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. CKR-051 SAD CKR-051 Dose 4 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. CKR-051 SAD Placebo Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. CKR-051 MAD CKR-051 Dose 2 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day. CKR-051 MAD CKR-051 Dose 3 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day. CKR-051 MAD CKR-051 Dose 4 Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day. CKR-051 MAD Placebo Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.
- Primary Outcome Measures
Name Time Method SAD : Safety and tolerability (Numeric pain rating scale) Day 1 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).
MAD : Safety and tolerability (Numeric pain rating scale) Day 1 to Day 21 (Everyday) 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).
- Secondary Outcome Measures
Name Time Method SAD : Pharmacokinetics (CL/F) Day 1 Assessment of the clearance of CKR-051
SAD : Pharmacokinetics (Cmax) Day 1 Assessment of the peak plasma concentration of CKR-051
SAD : Pharmacokinetics (AUC) Day 1 Assessment of the plasma area under the curve of CKR-051
SAD : Pharmacokinetics (Tmax) Day 1 Assessment of the time to Cmax of CKR-051
SAD : Pharmacokinetics (t1/2) Day 1 Assessment of the total elimination half life of CKR-051
SAD : Pharmacokinetics (Vz/F) Day 1 Assessment of the volume of distribution of CKR-051
MAD : Pharmacokinetics (Cmax) Day 1, 7, 14, 18, 19, 20 and 21 Assessment of the peak plasma concentration of CKR-051
MAD : Pharmacokinetics (AUC) Day 1, 7, 14, 18, 19, 20 and 21 Assessment of the plasma area under the curve of CKR-051
MAD : Pharmacokinetics (Tmax) Day 1, 7, 14, 18, 19, 20 and 21 Assessment of the time to Cmax of CKR-051
MAD : Pharmacokinetics (t1/2) Day 1, 7, 14, 18, 19, 20 and 21 Assessment of the total elimination half life of CKR-051
MAD : Pharmacokinetics (Vz/F) Day 1, 7, 14, 18, 19, 20 and 21 Assessment of the volume of distribution of CKR-051
MAD : Pharmacokinetics (CL/F) Day 1, 7, 14, 18, 19, 20 and 21 Assessment of the clearance of CKR-051
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of