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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2022-07-07

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.

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Detailed Description

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

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A1 (hzVSF-v13 50mg, intravenous, single dose)

Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, single dose)

Intervention Type 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)

Group A2 (hzVSF-v13 100mg, intravenous, single dose)

Single administration (intravenous) of 100mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, single dose)

Intervention Type 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)

Group A3 (hzVSF-v13 200mg, intravenous, single dose)

Single administration (intravenous) of 200mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, single dose)

Intervention Type 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)

Group A4 (hzVSF-v13 400mg, intravenous, single dose)

Single administration (intravenous) of 400mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, single dose)

Intervention Type 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)

Group A5 (hzVSF-v13 800mg, intravenous, single dose)

Single administration (intravenous) of 800mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, single dose)

Intervention Type 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)

Group A6 (hzVSF-v13 1200mg, intravenous, single dose)

Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, single dose)

Intervention Type 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)

Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)

Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1.

Group Type EXPERIMENTAL

hzVSF-v13 (subcutaneous, single dose)

Intervention Type DRUG

Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)

Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, multiple dose)

Intervention Type 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)

Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)

Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.

Group Type EXPERIMENTAL

hzVSF-v13 (intravenous, multiple dose)

Intervention Type 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)

Placebo (intravenous, single dose)

Single administration (intravenous) of placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo (intravenous, single dose)

Intervention Type DRUG

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)

Placebo (subcutaneous, single dose)

Single administration (subcutaneous) of placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo (subcutaneous, single dose)

Intervention Type DRUG

Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Placebo (intravenous, multiple dose)

Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57.

Group Type PLACEBO_COMPARATOR

Placebo (intravenous, multiple dose)

Intervention Type DRUG

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)

Interventions

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hzVSF-v13 (intravenous, single dose)

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)

Intervention Type DRUG

hzVSF-v13 (subcutaneous, single dose)

Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Intervention Type DRUG

hzVSF-v13 (intravenous, multiple dose)

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)

Intervention Type DRUG

Placebo (intravenous, single dose)

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)

Intervention Type DRUG

Placebo (subcutaneous, single dose)

Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Intervention Type DRUG

Placebo (intravenous, multiple dose)

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)

Intervention Type DRUG

Other Intervention Names

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a humanized monoclonal antibody (mAb) a humanized monoclonal antibody (mAb) a humanized monoclonal antibody (mAb) 0.9% Normal saline 0.9% Normal saline 0.9% Normal saline

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes