Healthy
Conditions
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).
Interventions
DRUGCKR-051 Dose 1
Subjects will be administered 5 g of CKR-051.
DRUGCKR-051 Dose 2
Subjects will be administered 10 g of CKR-051.
DRUGCKR-051 Dose 3
Subjects will be administered 10 g of CKR-051.
DRUGCKR-051 Dose 4
Subjects will be administered 10 g of CKR-051.
DRUGPlacebo
Placebo comparator.
Sponsors
CK Regeon Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
19 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| SAD : Pharmacokinetics (CL/F) | Day 1 | Assessment of the clearance of CKR-051 |
| MAD : Pharmacokinetics (Cmax) | Day 1, 7, 14, 18, 19, 20 and 21 | Assessment of the peak plasma concentration of CKR-051 |
| SAD : Pharmacokinetics (Cmax) | Day 1 | Assessment of the peak plasma concentration 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 |
| MAD : Pharmacokinetics (AUC) | Day 1, 7, 14, 18, 19, 20 and 21 | Assessment of the plasma area under the curve of CKR-051 |
| SAD : Pharmacokinetics (AUC) | Day 1 | Assessment of the plasma area under the curve of CKR-051 |
Countries
South Korea
Outcome results
None listed