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

January 18, 2024 updated by: CK Regeon Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 1
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).
Day 1 to Day 21 (Everyday)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAD : Pharmacokinetics (Cmax)
Time Frame: Day 1
Assessment of the peak plasma concentration of CKR-051
Day 1
SAD : Pharmacokinetics (AUC)
Time Frame: Day 1
Assessment of the plasma area under the curve of CKR-051
Day 1
SAD : Pharmacokinetics (Tmax)
Time Frame: Day 1
Assessment of the time to Cmax of CKR-051
Day 1
SAD : Pharmacokinetics (t1/2)
Time Frame: Day 1
Assessment of the total elimination half life of CKR-051
Day 1
SAD : Pharmacokinetics (Vz/F)
Time Frame: Day 1
Assessment of the volume of distribution of CKR-051
Day 1
SAD : Pharmacokinetics (CL/F)
Time Frame: Day 1
Assessment of the clearance of CKR-051
Day 1
MAD : Pharmacokinetics (Cmax)
Time Frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the peak plasma concentration of CKR-051
Day 1, 7, 14, 18, 19, 20 and 21
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
Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Tmax)
Time Frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the time to Cmax of CKR-051
Day 1, 7, 14, 18, 19, 20 and 21
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
Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Vz/F)
Time Frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the volume of distribution of CKR-051
Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (CL/F)
Time Frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the clearance of CKR-051
Day 1, 7, 14, 18, 19, 20 and 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CK Regeon Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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