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

NCT04817202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-02-15

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • ImmuneMed, Inc.

    lead INDUSTRY

Principal Investigators

  • +61-8-70887900 Wabnitz, phD · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-01-15
Completion
2022-07-07

Countries

  • Australia

Study Locations

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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 NCT04817202 on ClinicalTrials.gov