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

February 14, 2024 updated by: ImmuneMed, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • CMAX, Clinical Research Pty Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A1 (hzVSF-v13 50mg, intravenous, single dose)
Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group A2 (hzVSF-v13 100mg, intravenous, single dose)
Single administration (intravenous) of 100mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group A3 (hzVSF-v13 200mg, intravenous, single dose)
Single administration (intravenous) of 200mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group A4 (hzVSF-v13 400mg, intravenous, single dose)
Single administration (intravenous) of 400mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group A5 (hzVSF-v13 800mg, intravenous, single dose)
Single administration (intravenous) of 800mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group A6 (hzVSF-v13 1200mg, intravenous, single dose)
Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)
Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)
Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Experimental: Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)
Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.
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)
Other Names:
  • a humanized monoclonal antibody (mAb)
Placebo Comparator: Placebo (intravenous, single dose)
Single administration (intravenous) of placebo on Day 1.
Drug: Placebo (intravenous, single dose)
Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)
Other Names:
  • 0.9% Normal saline
Placebo Comparator: Placebo (subcutaneous, single dose)
Single administration (subcutaneous) of placebo on Day 1.
Drug: Placebo (subcutaneous, single dose)
Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
Other Names:
  • 0.9% Normal saline
Placebo Comparator: Placebo (intravenous, multiple dose)
Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57.
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)
Other Names:
  • 0.9% Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneMed, Inc.

Investigators

  • Principal Investigator: +61-8-70887900 Wabnitz, phD, CMAX Clinical Research Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

July 7, 2022

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hzVSF_v13-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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