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The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KM-023 | Experimental |
| |
| Placebo for KM-023 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KM-023 | Drug | -KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety/ Tolerability Evaluation | -number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC) | participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023 | -Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate AUC of KM-023 | participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000599300 | 3-(3-ethyl-5-isopropyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidine-4-carbonyl)-5-methylbenzonitrile |
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| Placebo for KM-023 | Drug | -Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days. |
|
| Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023 | -Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate Cmax of KM-023 | participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |