NCT03653208

Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers

Dose Blocked-randomized, Double-blind, Placebo Controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 After Intravenous Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: ImmuneMed, Inc. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the safety/tolerability and pharmacokinetic characteristics after single intravenous (IV) administration of hzVSF-v13 (humanized Virus Suppressing Factor-variant 13) in healthy male volunteers

Detailed description

Dose blocked-randomized, double-blind, placebo controlled, single dose, dose-escalation study to investigate the safety/tolerability and pharmacokinetic characteristics of hzVSF-v13 after IV administration in healthy male volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	hzVSF-v13	Dosage form: 10mg / 20mg / 50mg / 100mg / 200mg / 400mg / 800mg / 1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1 (single administration)
DRUG	Placebo	Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2018-08-31
• Last updated: 2021-04-27
• Results posted: 2021-04-02

Locations

1 site across 1 country: South Korea