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The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNC042 single dose | Experimental | HNC042,freeze-dried powder,single ascending doses Single dose, |
|
| Placebo single dose | Placebo Comparator | Placebo single ascending doses , Intravenous route Single dose |
|
| HNC042 multiple ascending doses | Experimental | HNC042,freeze-dried powder,multiple ascending doses, Intravenous route |
|
| Placebo, multiple ascending doses | Placebo Comparator | Placebo, multiple ascending doses, Intravenous route, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HNC042 single dose | Drug | HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events | Between screening and 7 days after the last dose |
| Number of subjects with abnormal laboratory | To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory | Between screening and 7days after the last dose |
| Number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram | Between screening and 7 days after the last dose |
| Number of subjects with abnormal physical examination | To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination | Between screening and 7 days after the last dose |
| Number of subjects with abnormal vital signs | To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs | Between screening and 7 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of HNC042 in plasma | To characterize the amount of HNC042 in plasma over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects | Between Day 1 predose and 24 hours after the (last) dose |
| The amount of HNC042 in urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paolo B. DePetrillo | Baltimore | Maryland | 21201 | United States |
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| Placebo single dose | Drug | Placebo single ascending doses , Intravenous route Single dose, matching placebo |
|
| HNC042 multiple ascending doses | Drug | HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg |
|
| Placebo multiple ascending doses | Drug | Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo |
|
To characterize the amount of HNC042 in urine over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects |
| Between Day 1 predose and 24 hours after the (last) dose |