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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKR-051 Dose 1 | Drug | Subjects will be administered 5 g of CKR-051. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Day 1 to Day 21 (Everyday) |
| Measure | Description | Time Frame |
|---|---|---|
| SAD : Pharmacokinetics (Cmax) | Assessment of the peak plasma concentration of CKR-051 | Day 1 |
| SAD : Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CKR-051 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| CKR-051 Dose 2 |
| Drug |
Subjects will be administered 10 g of CKR-051. |
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| CKR-051 Dose 3 | Drug | Subjects will be administered 10 g of CKR-051. |
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| CKR-051 Dose 4 | Drug | Subjects will be administered 10 g of CKR-051. |
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| Placebo | Drug | Placebo comparator. |
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| Day 1 |
| SAD : Pharmacokinetics (Tmax) | Assessment of the time to Cmax of CKR-051 | Day 1 |
| SAD : Pharmacokinetics (t1/2) | Assessment of the total elimination half life of CKR-051 | Day 1 |
| SAD : Pharmacokinetics (Vz/F) | Assessment of the volume of distribution of CKR-051 | Day 1 |
| SAD : Pharmacokinetics (CL/F) | Assessment of the clearance of CKR-051 | Day 1 |
| MAD : Pharmacokinetics (Cmax) | Assessment of the peak plasma concentration of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |
| MAD : Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |
| MAD : Pharmacokinetics (Tmax) | Assessment of the time to Cmax of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |
| MAD : Pharmacokinetics (t1/2) | Assessment of the total elimination half life of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |
| MAD : Pharmacokinetics (Vz/F) | Assessment of the volume of distribution of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |
| MAD : Pharmacokinetics (CL/F) | Assessment of the clearance of CKR-051 | Day 1, 7, 14, 18, 19, 20 and 21 |