NCT04817202

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: ImmuneMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-09-16
• Primary completion: 2022-01-15
• Completion: 2022-07-07
• First posted: 2021-03-26
• Last updated: 2024-02-15

Locations

1 site across 1 country: Australia