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This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KMRC011 5μg or Placebo | Other | Cohort 1 |
|
| KMRC011 10μg or Placebo | Other | Cohort 2 |
|
| KMRC011 15μg or Placebo | Other | Cohort 3 |
|
| KMRC011 20μg or Placebo | Other | Cohort 4 |
|
| KMRC011 25μg or Placebo | Other | Cohort 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KMRC011 5μg or Placebo | Drug | Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse event or adverse drug reaction | Up to 7±1 days after injection | |
| Number of subjects with clinically significant changes in hematology test result after injection | Up to 7±1 days after injection | |
| Number of subjects with clinically significant changes in blood chemistry test result after injection | Up to 7±1 days after injection | |
| Number of subjects with clinically significant changes in urinalysis test result after injection | Up to 7±1 days after injection | |
| Number of subjects with clinically significant changes in blood coagulation test result after injection | Up to 7±1 days after injection | |
| Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection | Up to 7±1 days after injection | |
| Number of subjects with clinically significant changes in vital sign after injection | Up to 7±1 days after injection | |
| Number of subjects with clinically significant physical abnormality after injection | Up to 7±1 days after injection | |
| Maximum serum concentration (Cmax) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of KMRC011 | A dose that is one level lower than the dose which Dose Limiting Toxicity (DLT) incidence is 33% or more is determined as a Maximum Tolerated Dose (MTD). If the Dose Limiting Toxicity (DLT) incidence is lower than 33% at all doses level, we conclude Maximum Tolerated Dose (MTD) cannot be determined. | Until the study completion, approximately up to 35 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who expressed Anti-Drug (KMRC011) Antibody (ADA) | Up to 28±2 days after injection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Ryul Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Gangnam-gu | Seoul | 06351 | South Korea |
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| KMRC011 10μg or Placebo | Drug | Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml |
|
|
| KMRC011 15μg or Placebo | Drug | Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml |
|
|
| KMRC011 20μg or Placebo | Drug | Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml |
|
|
| KMRC011 25μg or Placebo | Drug | Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml |
|
|
| Time of the maximum serum concentration (Tmax) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Area under the serum concentration versus time curve, from time 0 to the last measurable concentration (AUC0-t) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity (AUCextra) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Apparent clearance (CL/F) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Apparent volume of distribution (Vd/F) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Terminal half-life (t1/2) of KMRC011 | Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose |
| Maximum effect over the time span specified (Emax) of G-CSF | Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose |
| Maximum effect over the time span specified (Emax) of IL-6 | Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose |
| Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of G-CSF | Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose |
| Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of IL-6 | Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose |
| ID | Term |
|---|---|
| D054508 | Acute Radiation Syndrome |
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000657341 | KMRC011 |
| C423142 | KPNA1 protein, human |
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