NCT04817202 - Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 16, 2020

Primary Completion Date

January 15, 2022

Study Completion Date

July 7, 2022

Conditions

Healthy Volunteers

Interventions

DRUG

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)

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)

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)

DRUG

Placebo (intravenous, single dose)

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

DRUG

Placebo (subcutaneous, single dose)

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

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)

Trial Locations (1)

5000

CMAX, Clinical Research Pty Ltd., Adelaide