At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
hzVSF-v13 +1 moredrug
Likely dose
hzVSF-v13 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating hzVSF-v13 and Placebo for Healthy. Completed, enrolled 56 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartNov 2018
Primary CompletionFeb 2020
TodayJul 2026
First PostedAug 31, 2018
Enrollment StartNov 20, 2018
Primary CompletionFeb 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.8 years ago
Interventions
hzVSF-v13drug
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)
Placebodrug
Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)