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Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo in healthy subjects.
A phase I, double-blind, placebo-controlled, single and multiple dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 (hzVSF-v13 50mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 50mg hzVSF-v13 on Day 1. |
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| Group A2 (hzVSF-v13 100mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 100mg hzVSF-v13 on Day 1. |
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| Group A3 (hzVSF-v13 200mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 200mg hzVSF-v13 on Day 1. |
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| Group A4 (hzVSF-v13 400mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 400mg hzVSF-v13 on Day 1. |
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| Group A5 (hzVSF-v13 800mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 800mg hzVSF-v13 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hzVSF-v13 (intravenous, single dose) | Drug | Dosage form: 50mg / 100mg / 200mg / 400mg / 800mg /1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1 (single administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline QTc interval at each time point | Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100~300Hz | Group A1~A7: Day 1 (pre-dose), Day 8, Day 15, Day 22, Day 29, Day 36, Day 50, Day 64, Day 78, Day 92 Group B1~B2: Day 1 (pre-dose), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 98, Day 162 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic - Cmax | Maximum observed Concentration of hzVSF-v13 | Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98 |
| Pharmacokinetic - AUC0-∞ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| +61-8-70887900 Wabnitz, phD | CMAX Clinical Research Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX, Clinical Research Pty Ltd. | Adelaide | South Australia | 5000 | Australia |
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| Group A6 (hzVSF-v13 1200mg, intravenous, single dose) |
| Experimental |
Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1. |
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| Group A7 (hzVSF-v13 100mg, subcutaneous, single dose) | Experimental | Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1. |
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| Group B1 (hzVSF-v13 100mg, intravenous, multiple dose) | Experimental | Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. |
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| Group B2 (hzVSF-v13 400mg, intravenous, multiple dose) | Experimental | Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. |
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| Placebo (intravenous, single dose) | Placebo Comparator | Single administration (intravenous) of placebo on Day 1. |
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| Placebo (subcutaneous, single dose) | Placebo Comparator | Single administration (subcutaneous) of placebo on Day 1. |
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| Placebo (intravenous, multiple dose) | Placebo Comparator | Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57. |
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| hzVSF-v13 (subcutaneous, single dose) | Drug | Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration) |
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| hzVSF-v13 (intravenous, multiple dose) | Drug | Dosage form: 100mg / 400mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration) |
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| Placebo (intravenous, single dose) | Drug | Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration) |
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| Placebo (subcutaneous, single dose) | Drug | Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration) |
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| Placebo (intravenous, multiple dose) | Drug | Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration) |
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Area under the plasma concentration-time curve (AUC) from time zero to infinity |
| Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98 |
| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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