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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04817202




Registration number
NCT04817202
Ethics application status
Date submitted
22/03/2021
Date registered
26/03/2021
Date last updated
15/02/2024

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
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
Secondary ID [1] 0 0
hzVSF_v13-0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes from baseline QTc interval at each time point
Timepoint [1] 0 0
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 [1] 0 0
Pharmacokinetic - Cmax
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Pharmacokinetic - AUC0-8
Timepoint [2] 0 0
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

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2022
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX, Clinical Research Pty Ltd. - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImmuneMed, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04817202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
+61-8-70887900 Wabnitz, phD
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04817202