Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)

Study Overview
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Brief Summary
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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.

Detailed Description
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A phase I, double-blind, placebo-controlled, single and multiple dose

Official Title
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hzVSF-v13 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics After Intravenous and Subcutaneous Administration in Healthy Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: hzVSF-v13 (intravenous, single dose)
* Drug: hzVSF-v13 (subcutaneous, single dose)
* Drug: hzVSF-v13 (intravenous, multiple dose)
* Drug: Placebo (intravenous, single dose)
* Drug: Placebo (subcutaneous, single dose)
* Drug: Placebo (intravenous, multiple dose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening. Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A1 (hzVSF-v13 50mg, intravenous, single dose)<br>Single administration (intravenous) of 50mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (intravenous, single dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group A2 (hzVSF-v13 100mg, intravenous, single dose)<br>Single administration (intravenous) of 100mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (intravenous, single dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group A3 (hzVSF-v13 200mg, intravenous, single dose)<br>Single administration (intravenous) of 200mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (intravenous, single dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group A4 (hzVSF-v13 400mg, intravenous, single dose)<br>Single administration (intravenous) of 400mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (intravenous, single dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group A5 (hzVSF-v13 800mg, intravenous, single dose)<br>Single administration (intravenous) of 800mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (intravenous, single dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group A6 (hzVSF-v13 1200mg, intravenous, single dose)<br>Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (intravenous, single dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)<br>Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1. | Drug: hzVSF-v13 (subcutaneous, single dose)<br>* Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)<br>Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. | Drug: hzVSF-v13 (intravenous, multiple dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Experimental: Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)<br>Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. | Drug: hzVSF-v13 (intravenous, multiple dose)<br>* 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)<br>* Other names: a humanized monoclonal antibody (mAb);|
| Placebo Comparator: Placebo (intravenous, single dose)<br>Single administration (intravenous) of placebo on Day 1. | Drug: Placebo (intravenous, single dose)<br>* Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)<br>* Other names: 0.9% Normal saline;|
| Placebo Comparator: Placebo (subcutaneous, single dose)<br>Single administration (subcutaneous) of placebo on Day 1. | Drug: Placebo (subcutaneous, single dose)<br>* Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)<br>* Other names: 0.9% Normal saline;|
| Placebo Comparator: Placebo (intravenous, multiple dose)<br>Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57. | Drug: Placebo (intravenous, multiple dose)<br>* Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)<br>* Other names: 0.9% Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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-∞ | 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 |