Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT05833906
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).
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Notify Me19 year–60 year
Male
Interventional
Phase 1
Seoul, 03080, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects will be administered 5 g of CKR-051.
Subjects will be administered 10 g of CKR-051.
Subjects will be administered 10 g of CKR-051.
Subjects will be administered 10 g of CKR-051.
Placebo comparator.
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).
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).
Time frame: Day 1
Assessment of the peak plasma concentration of CKR-051
Time frame: Day 1
Assessment of the plasma area under the curve of CKR-051
Time frame: Day 1
Assessment of the time to Cmax of CKR-051
Time frame: Day 1
Assessment of the total elimination half life of CKR-051
Time frame: Day 1
Assessment of the volume of distribution of CKR-051
Time frame: Day 1
Assessment of the clearance of CKR-051
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the peak plasma concentration of CKR-051
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the plasma area under the curve of CKR-051
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the time to Cmax of CKR-051
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the total elimination half life of CKR-051
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the volume of distribution of CKR-051
Time frame: Day 1, 7, 14, 18, 19, 20 and 21
Assessment of the clearance of CKR-051
CK Regeon Inc.
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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