NCT05833906

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2023

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

March 23, 2023

Last Update Submit

January 18, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

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.

Drug: CKR-051 Dose 1Drug: CKR-051 Dose 2Drug: CKR-051 Dose 3Drug: CKR-051 Dose 4Drug: Placebo

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.

Drug: CKR-051 Dose 2Drug: CKR-051 Dose 3Drug: CKR-051 Dose 4Drug: Placebo

Interventions

CKR-051 Dose 1DRUG

Subjects will be administered 5 g of CKR-051.

CKR-051 SAD
CKR-051 Dose 2DRUG

Subjects will be administered 10 g of CKR-051.

CKR-051 MADCKR-051 SAD
CKR-051 Dose 3DRUG

Subjects will be administered 10 g of CKR-051.

CKR-051 MADCKR-051 SAD
CKR-051 Dose 4DRUG

Subjects will be administered 10 g of CKR-051.

CKR-051 MADCKR-051 SAD
PlaceboDRUG

Placebo comparator.

CKR-051 MADCKR-051 SAD

Eligibility Criteria

Age19 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 27, 2023

Study Start

April 25, 2023

Primary Completion

January 8, 2024

Study Completion

January 8, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

KR(1)