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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: CKR-051 Dose 1; Drug: CKR-051 Dose 2; Drug: CKR-051 Dose 3; Drug: CKR-051 Dose 4

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKR-051 SAD; Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.	Drug: Placebo; Placebo comparator.; Drug: CKR-051 Dose 1; Subjects will be administered 5 g of CKR-051.; Drug: CKR-051 Dose 2; Subjects will be administered 10 g of CKR-051.; Drug: CKR-051 Dose 3; Subjects will be administered 10 g of CKR-051.; Drug: CKR-051 Dose 4; Subjects will be administered 10 g of CKR-051.
Experimental: CKR-051 MAD; Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.	Drug: Placebo; Placebo comparator.; Drug: CKR-051 Dose 2; Subjects will be administered 10 g of CKR-051.; Drug: CKR-051 Dose 3; Subjects will be administered 10 g of CKR-051.; Drug: CKR-051 Dose 4; Subjects will be administered 10 g of CKR-051.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD : Safety and tolerability (Numeric pain rating scale)	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).	Day 1
MAD : Safety and tolerability (Numeric pain rating scale)	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).	Day 1 to Day 21 (Everyday)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD : Pharmacokinetics (Cmax)	Assessment of the peak plasma concentration of CKR-051	Day 1
SAD : Pharmacokinetics (AUC)	Assessment of the plasma area under the curve of CKR-051	Day 1
SAD : Pharmacokinetics (Tmax)	Assessment of the time to Cmax of CKR-051	Day 1
SAD : Pharmacokinetics (t1/2)	Assessment of the total elimination half life of CKR-051	Day 1
SAD : Pharmacokinetics (Vz/F)	Assessment of the volume of distribution of CKR-051	Day 1
SAD : Pharmacokinetics (CL/F)	Assessment of the clearance of CKR-051	Day 1
MAD : Pharmacokinetics (Cmax)	Assessment of the peak plasma concentration of CKR-051	Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (AUC)	Assessment of the plasma area under the curve of CKR-051	Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Tmax)	Assessment of the time to Cmax of CKR-051	Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (t1/2)	Assessment of the total elimination half life of CKR-051	Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Vz/F)	Assessment of the volume of distribution of CKR-051	Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (CL/F)	Assessment of the clearance of CKR-051	Day 1, 7, 14, 18, 19, 20 and 21

Collaborators and Investigators

• Sponsor: CK Regeon Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): January 8, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: COSMOS-21-RegenT-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No