Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects
NCT05833906 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2024-01-19
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).
Conditions
- Healthy
Interventions
- 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.
- DRUG
-
Placebo comparator.
Sponsors & Collaborators
-
CK Regeon Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 60 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-25
- Primary Completion
- 2024-01-08
- Completion
- 2024-01-08
Countries
- South Korea
Study Locations
More Related Trials
-
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
NCT00069446 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
NCT00797706 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus
NCT01629199 ·Status: COMPLETED ·Phase: PHASE3
-
Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous Leg
NCT05319106 ·Status: RECRUITING ·Phase: NA
-
Efficacy and Safety Evaluation of the Intralesional Recombinant Human Epidermal Growth Factor (rhEGF) in Subjects With Diabetic Foot Ulcer.
NCT02554851 ·Status: UNKNOWN ·Phase: PHASE3
-
Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers
NCT05797285 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
NCT00387101 ·Status: TERMINATED ·Phase: PHASE3
-
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
NCT06511596 ·Status: COMPLETED ·Phase: NA
-
Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities
NCT00493051 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
NCT05930210 ·Status: RECRUITING ·Phase: PHASE3
-
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
NCT06852976 ·Status: RECRUITING ·Phase: PHASE2
-
Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.
NCT05595681 ·Status: TERMINATED ·Phase: PHASE1
-
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
NCT00709514 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
NCT04962139 ·Status: TERMINATED ·Phase: PHASE3
-
Allogeneic ABCB5-positive Stem Cells for Treatment of CVU
NCT03257098 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers
NCT05165628 ·Status: COMPLETED ·Phase: PHASE1
-
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
NCT00425178 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers
NCT03603431 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.
NCT04569409 ·Status: COMPLETED ·Phase: PHASE3
-
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers
NCT05165459 ·Status: UNKNOWN ·Phase: NA
-
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
NCT01849965 ·Status: TERMINATED ·Phase: PHASE3
-
CSTC1 for Diabetic Foot Ulcers Phase II Study
NCT01813305 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients
NCT02367690 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
NCT02987101 ·Status: UNKNOWN ·Phase: NA
-
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
NCT03865394 ·Status: COMPLETED ·Phase: PHASE1/PHASE2