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

NCT03653208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-04-27

Study results available
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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

Conditions

  • Healthy

Interventions

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)

Sponsors & Collaborators

  • ImmuneMed, Inc.

    lead INDUSTRY

Principal Investigators

  • In-Jin Jang, M.D · Seoul National University College of Medicine/Seoul National University Hospital Department of Clinical Pharmacology and Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653208 on ClinicalTrials.gov