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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833906
• Other study ID #: COSMOS-21-RegenT-1
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2023
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: CK Regeon Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CKR-051 Dose 1
Subjects will be administered 5 g of CKR-051.
• CKR-051 Dose 2
Subjects will be administered 10 g of CKR-051.
• CKR-051 Dose 3
Subjects will be administered 10 g of CKR-051.
• CKR-051 Dose 4
Subjects will be administered 10 g of CKR-051.
• Placebo
Placebo comparator.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CK Regeon Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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