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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04817202
Registration number
NCT04817202
Ethics application status
Date submitted
22/03/2021
Date registered
26/03/2021
Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
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Scientific 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
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Secondary ID [1]
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hzVSF_v13-0002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - hzVSF-v13 (intravenous, single dose)
Treatment: Drugs - hzVSF-v13 (subcutaneous, single dose)
Treatment: Drugs - hzVSF-v13 (intravenous, multiple dose)
Treatment: Drugs - Placebo (intravenous, single dose)
Treatment: Drugs - Placebo (subcutaneous, single dose)
Treatment: Drugs - Placebo (intravenous, multiple dose)
Experimental: Group A1 (hzVSF-v13 50mg, intravenous, single dose) - Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.
Experimental: Group A2 (hzVSF-v13 100mg, intravenous, single dose) - Single administration (intravenous) of 100mg hzVSF-v13 on Day 1.
Experimental: Group A3 (hzVSF-v13 200mg, intravenous, single dose) - Single administration (intravenous) of 200mg hzVSF-v13 on Day 1.
Experimental: Group A4 (hzVSF-v13 400mg, intravenous, single dose) - Single administration (intravenous) of 400mg hzVSF-v13 on Day 1.
Experimental: Group A5 (hzVSF-v13 800mg, intravenous, single dose) - Single administration (intravenous) of 800mg hzVSF-v13 on Day 1.
Experimental: Group A6 (hzVSF-v13 1200mg, intravenous, single dose) - Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1.
Experimental: Group A7 (hzVSF-v13 100mg, subcutaneous, single dose) - Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1.
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.
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.
Placebo comparator: Placebo (intravenous, single dose) - Single administration (intravenous) of placebo on Day 1.
Placebo comparator: Placebo (subcutaneous, single dose) - Single administration (subcutaneous) of placebo on Day 1.
Placebo comparator: Placebo (intravenous, multiple dose) - Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57.
Treatment: Drugs: 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)
Treatment: Drugs: 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)
Treatment: Drugs: 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)
Treatment: Drugs: Placebo (intravenous, single dose)
Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)
Treatment: Drugs: Placebo (subcutaneous, single dose)
Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
Treatment: Drugs: 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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Changes from baseline QTc interval at each time point
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Assessment method [1]
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Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100\~300Hz
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Timepoint [1]
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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
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Secondary outcome [1]
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Pharmacokinetic - Cmax
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Assessment method [1]
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Maximum observed Concentration of hzVSF-v13
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Timepoint [1]
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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
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Secondary outcome [2]
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Pharmacokinetic - AUC0-8
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Assessment method [2]
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Area under the plasma concentration-time curve (AUC) from time zero to infinity
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Timepoint [2]
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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
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/07/2022
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Sample size
Target
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX, Clinical Research Pty Ltd. - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ImmuneMed, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT04817202
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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+61-8-70887900 Wabnitz, phD
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Address
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CMAX Clinical Research Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04817202