HealthyPhase 1NCT05833906
Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects
A Phase 1 study testing CKR-051 Dose 1, CKR-051 Dose 2 and CKR-051 Dose 3 in people with Healthy, run by CK Regeon Inc. at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CKR-051 Dose 1, CKR-051 Dose 2 and CKR-051 Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2023to 8 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Alcohol > 21 units/week
- Smoker
- Eating food containing a grapefruit
- Caffeine > 5 units/day
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Healthy
- Being tested
- CKR-051 Dose 1, CKR-051 Dose 2, CKR-051 Dose 3, CKR-051 Dose 4, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKR-051 Dose 1Drug
Subjects will be administered 5 g of CKR-051.
CKR-051 Dose 2Drug
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 3Drug
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 4Drug
Subjects will be administered 10 g of CKR-051.
PlaceboDrug
Placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CKR-051 Dose 1; Drug: CKR-051 Dose 2; Drug: CKR-051 Dose 3; Drug: CKR-051 Dose 4; Drug: 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. Receives: Drug: CKR-051 Dose 2; Drug: CKR-051 Dose 3; Drug: CKR-051 Dose 4; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 1 to Day 21 (Everyday)
Secondary outcomes (12)
SAD : Pharmacokinetics (Cmax)
Assessment of the peak plasma concentration of CKR-051
Measured: Day 1
SAD : Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CKR-051
Measured: Day 1
SAD : Pharmacokinetics (Tmax)
Assessment of the time to Cmax of CKR-051
Measured: Day 1
SAD : Pharmacokinetics (t1/2)
Assessment of the total elimination half life of CKR-051
Measured: Day 1
SAD : Pharmacokinetics (Vz/F)
Assessment of the volume of distribution of CKR-051
Measured: Day 1
SAD : Pharmacokinetics (CL/F)
Assessment of the clearance of CKR-051
Measured: Day 1
MAD : Pharmacokinetics (Cmax)
Assessment of the peak plasma concentration of CKR-051
Measured: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CKR-051
Measured: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Tmax)
Assessment of the time to Cmax of CKR-051
Measured: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (t1/2)
Assessment of the total elimination half life of CKR-051
Measured: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Vz/F)
Assessment of the volume of distribution of CKR-051
Measured: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (CL/F)
Assessment of the clearance of CKR-051
Measured: Day 1, 7, 14, 18, 19, 20 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start25 Apr 2023
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CK Regeon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833906
- Sponsor's protocol ID
- COSMOS-21-RegenT-1
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05833906
- Acronym / sponsor ID
- COSMOS-21-RegenT-1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CK Regeon Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKR-051 SAD | Experimental | Drug: CKR-051 Dose 1, Drug: CKR-051 Dose 2, Drug: CKR-051 Dose 3, Drug: CKR-051 Dose 4, Drug: PlaceboParticipants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day. |
| CKR-051 MAD | Experimental | Drug: CKR-051 Dose 2, Drug: CKR-051 Dose 3, Drug: CKR-051 Dose 4, Drug: PlaceboParticipants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKR-051 Dose 1Subjects will be administered 5 g of CKR-051. | Drug | CKR-051 SAD |
| CKR-051 Dose 2Subjects will be administered 10 g of CKR-051. | Drug | CKR-051 MAD, CKR-051 SAD |
| CKR-051 Dose 3Subjects will be administered 10 g of CKR-051. | Drug | CKR-051 MAD, CKR-051 SAD |
| CKR-051 Dose 4Subjects will be administered 10 g of CKR-051. | Drug | CKR-051 MAD, CKR-051 SAD |
| PlaceboPlacebo comparator. | Drug | CKR-051 MAD, CKR-051 SAD |
Primary outcome
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).
12 secondary outcomes
SAD : Pharmacokinetics (Cmax)
Time frame: Day 1
SAD : Pharmacokinetics (AUC)
Time frame: Day 1
SAD : Pharmacokinetics (Tmax)
Time frame: Day 1
SAD : Pharmacokinetics (t1/2)
Time frame: Day 1
SAD : Pharmacokinetics (Vz/F)
Time frame: Day 1
SAD : Pharmacokinetics (CL/F)
Time frame: Day 1
MAD : Pharmacokinetics (Cmax)
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (AUC)
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Tmax)
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (t1/2)
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (Vz/F)
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
MAD : Pharmacokinetics (CL/F)
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKR-051 Dose 1, CKR-051 Dose 2 and CKR-051 Dose 3 in people with Healthy, run by CK Regeon Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD : Safety and tolerability (Numeric pain rating scale) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.