Clinical trial NCT05833906: Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CK Regeon Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-27
Enrollment: 52
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).


Eligibility 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

Primary outcomes:
measure: SAD : Safety and tolerability (Numeric pain rating scale)
timeFrame: Day 1
measure: MAD : Safety and tolerability (Numeric pain rating scale)
timeFrame: Day 1 to Day 21 (Everyday)
Secondary outcomes:
measure: SAD : Pharmacokinetics (Cmax)
timeFrame: Day 1
measure: SAD : Pharmacokinetics (AUC)
timeFrame: Day 1
measure: SAD : Pharmacokinetics (Tmax)
timeFrame: Day 1
measure: SAD : Pharmacokinetics (t1/2)
timeFrame: Day 1
measure: SAD : Pharmacokinetics (Vz/F)
timeFrame: Day 1
measure: SAD : Pharmacokinetics (CL/F)
timeFrame: Day 1
measure: MAD : Pharmacokinetics (Cmax)
timeFrame: Day 1, 7, 14, 18, 19, 20 and 21
measure: MAD : Pharmacokinetics (AUC)
timeFrame: Day 1, 7, 14, 18, 19, 20 and 21
measure: MAD : Pharmacokinetics (Tmax)
timeFrame: Day 1, 7, 14, 18, 19, 20 and 21
measure: MAD : Pharmacokinetics (t1/2)
timeFrame: Day 1, 7, 14, 18, 19, 20 and 21
measure: MAD : Pharmacokinetics (Vz/F)
timeFrame: Day 1, 7, 14, 18, 19, 20 and 21
measure: MAD : Pharmacokinetics (CL/F)
timeFrame: Day 1, 7, 14, 18, 19, 20 and 21
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: