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Completed

NCT Number: NCT05833906

Safety, Tolerability, and Pharmacokinetic Evaluations 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).

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Key information

Conditions

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKR-051 Dose 1

Drug

Subjects will be administered 5 g of CKR-051.

CKR-051 Dose 2

Drug

Subjects will be administered 10 g of CKR-051.

CKR-051 Dose 3

Drug

Subjects will be administered 10 g of CKR-051.

CKR-051 Dose 4

Drug

Subjects will be administered 10 g of CKR-051.

Placebo

Drug

Placebo comparator.

Primary outcomes

  1. SAD : Safety and tolerability (Numeric pain rating scale)

    Time frame: 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).

  2. MAD : Safety and tolerability (Numeric pain rating scale)

    Time frame: 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 outcomes

  1. SAD : Pharmacokinetics (Cmax)

    Time frame: Day 1

    Assessment of the peak plasma concentration of CKR-051

  2. SAD : Pharmacokinetics (AUC)

    Time frame: Day 1

    Assessment of the plasma area under the curve of CKR-051

  3. SAD : Pharmacokinetics (Tmax)

    Time frame: Day 1

    Assessment of the time to Cmax of CKR-051

  4. SAD : Pharmacokinetics (t1/2)

    Time frame: Day 1

    Assessment of the total elimination half life of CKR-051

  5. SAD : Pharmacokinetics (Vz/F)

    Time frame: Day 1

    Assessment of the volume of distribution of CKR-051

  6. SAD : Pharmacokinetics (CL/F)

    Time frame: Day 1

    Assessment of the clearance of CKR-051

  7. MAD : Pharmacokinetics (Cmax)

    Time frame: Day 1, 7, 14, 18, 19, 20 and 21

    Assessment of the peak plasma concentration of CKR-051

  8. MAD : Pharmacokinetics (AUC)

    Time frame: Day 1, 7, 14, 18, 19, 20 and 21

    Assessment of the plasma area under the curve of CKR-051

  9. MAD : Pharmacokinetics (Tmax)

    Time frame: Day 1, 7, 14, 18, 19, 20 and 21

    Assessment of the time to Cmax of CKR-051

  10. MAD : Pharmacokinetics (t1/2)

    Time frame: Day 1, 7, 14, 18, 19, 20 and 21

    Assessment of the total elimination half life of CKR-051

  11. MAD : Pharmacokinetics (Vz/F)

    Time frame: Day 1, 7, 14, 18, 19, 20 and 21

    Assessment of the volume of distribution of CKR-051

  12. MAD : Pharmacokinetics (CL/F)

    Time frame: Day 1, 7, 14, 18, 19, 20 and 21

    Assessment of the clearance of CKR-051

Sponsors and collaborators

Lead sponsor

CK Regeon Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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