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Clinical Trials/NCT05833906
NCT05833906CompletedPhase 1

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.

CK Regeon Inc.1 site in 1 country52 target enrollmentStarted: April 25, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
SAD : Safety and tolerability (Numeric pain rating scale)

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

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
  • Eating food containing a grapefruit
  • Caffeine > 5 units/day

Arms & Interventions

CKR-051 SAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.

Intervention: CKR-051 Dose 1 (Drug)

CKR-051 SAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.

Intervention: CKR-051 Dose 2 (Drug)

CKR-051 SAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.

Intervention: CKR-051 Dose 3 (Drug)

CKR-051 SAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.

Intervention: CKR-051 Dose 4 (Drug)

CKR-051 SAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.

Intervention: Placebo (Drug)

CKR-051 MAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.

Intervention: CKR-051 Dose 2 (Drug)

CKR-051 MAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.

Intervention: CKR-051 Dose 3 (Drug)

CKR-051 MAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.

Intervention: CKR-051 Dose 4 (Drug)

CKR-051 MAD

Experimental

Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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).

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

  • SAD : Pharmacokinetics (Cmax)(Day 1)
  • SAD : Pharmacokinetics (AUC)(Day 1)
  • SAD : Pharmacokinetics (Tmax)(Day 1)
  • SAD : Pharmacokinetics (t1/2)(Day 1)
  • SAD : Pharmacokinetics (Vz/F)(Day 1)
  • SAD : Pharmacokinetics (CL/F)(Day 1)
  • MAD : Pharmacokinetics (Cmax)(Day 1, 7, 14, 18, 19, 20 and 21)
  • MAD : Pharmacokinetics (AUC)(Day 1, 7, 14, 18, 19, 20 and 21)
  • MAD : Pharmacokinetics (Tmax)(Day 1, 7, 14, 18, 19, 20 and 21)
  • MAD : Pharmacokinetics (t1/2)(Day 1, 7, 14, 18, 19, 20 and 21)
  • MAD : Pharmacokinetics (Vz/F)(Day 1, 7, 14, 18, 19, 20 and 21)
  • MAD : Pharmacokinetics (CL/F)(Day 1, 7, 14, 18, 19, 20 and 21)

Investigators

Sponsor
CK Regeon Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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