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OpenTrials
Completed

NCT Number: NCT04817202

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX, Clinical Research Pty Ltd.

Adelaide, South Australia, 5000, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening.
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening.

Exclusion criteria

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).

Treatment and study plan

hzVSF-v13 (intravenous, single dose)

Drug

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)

Other names: a humanized monoclonal antibody (mAb)

hzVSF-v13 (subcutaneous, single dose)

Drug

Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Other names: a humanized monoclonal antibody (mAb)

hzVSF-v13 (intravenous, multiple dose)

Drug

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)

Other names: a humanized monoclonal antibody (mAb)

Placebo (intravenous, single dose)

Drug

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)

Other names: 0.9% Normal saline

Placebo (subcutaneous, single dose)

Drug

Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Other names: 0.9% Normal saline

Placebo (intravenous, multiple dose)

Drug

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)

Other names: 0.9% Normal saline

Primary outcomes

  1. Changes from baseline QTc interval at each time point

    Time frame: Group A1~A7: Day 1 (pre-dose), Day 8, Day 15, Day 22, Day 29, Day 36, Day 50, Day 64, Day 78, Day 92 Group B1~B2: Day 1 (pre-dose), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 98, Day 162

    Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100~300Hz

Secondary outcomes

  1. Pharmacokinetic - Cmax

    Time frame: Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98

    Maximum observed Concentration of hzVSF-v13

  2. Pharmacokinetic - AUC0-∞

    Time frame: Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98

    Area under the plasma concentration-time curve (AUC) from time zero to infinity

Sponsors and collaborators

Lead sponsor

ImmuneMed, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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