Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects
NCT ID: NCT05833906
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2023-04-25
2024-01-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study aiming to develop an agent for skin regeneration; potential treatments include acute and chronic wounds (c.f. Diabetic foot ulcers).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers
NCT00351767
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
NCT02833389
Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
NCT05095389
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
NCT00330265
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
NCT01831804
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
CKR-051 Dose 1
Subjects will be administered 5 g of CKR-051.
CKR-051 Dose 2
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 3
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 4
Subjects will be administered 10 g of CKR-051.
Placebo
Placebo comparator.
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.
CKR-051 Dose 2
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 3
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 4
Subjects will be administered 10 g of CKR-051.
Placebo
Placebo comparator.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CKR-051 Dose 1
Subjects will be administered 5 g of CKR-051.
CKR-051 Dose 2
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 3
Subjects will be administered 10 g of CKR-051.
CKR-051 Dose 4
Subjects will be administered 10 g of CKR-051.
Placebo
Placebo comparator.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
60 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CK Regeon Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COSMOS-21-RegenT-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.