Healthy VolunteersPhase 1NCT04817202
Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
A Phase 1 study testing hzVSF-v13 (intravenous, single dose), hzVSF-v13 (subcutaneous, single dose) and hzVSF-v13 (intravenous, multiple dose) in people with Healthy Volunteers, run by ImmuneMed, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- hzVSF-v13 (intravenous, single dose), hzVSF-v13 (subcutaneous, single dose) and hzVSF-v13 (intravenous, multiple dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Sep 2020to 7 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX, Clinical Research Pty Ltd.
Adelaide, South Australia, 5000
About this study
Official 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
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.
Read the detailed description
A phase I, double-blind, placebo-controlled, single and multiple dose
- Conditions
- Healthy Volunteers
- Being tested
- hzVSF-v13 (intravenous, single dose), hzVSF-v13 (subcutaneous, single dose), hzVSF-v13 (intravenous, multiple dose), Placebo (intravenous, single dose), Placebo (subcutaneous, single dose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hzVSF-v13 (intravenous, single dose)Drug
Also called a humanized monoclonal antibody (mAb)
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)
hzVSF-v13 (subcutaneous, single dose)Drug
Also called a humanized monoclonal antibody (mAb)
Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
hzVSF-v13 (intravenous, multiple dose)Drug
Also called a humanized monoclonal antibody (mAb)
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)
Placebo (intravenous, single dose)Drug
Also called 0.9% Normal saline
Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)
Placebo (subcutaneous, single dose)Drug
Also called 0.9% Normal saline
Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
Placebo (intravenous, multiple dose)Drug
Also called 0.9% Normal saline
Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
| Study group | Role | What they receive |
|---|---|---|
| Group A1 (hzVSF-v13 50mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 50mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (intravenous, single dose) |
| Group A2 (hzVSF-v13 100mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 100mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (intravenous, single dose) |
| Group A3 (hzVSF-v13 200mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 200mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (intravenous, single dose) |
| Group A4 (hzVSF-v13 400mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 400mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (intravenous, single dose) |
| Group A5 (hzVSF-v13 800mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 800mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (intravenous, single dose) |
| Group A6 (hzVSF-v13 1200mg, intravenous, single dose) | Experimental | Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (intravenous, single dose) |
| Group A7 (hzVSF-v13 100mg, subcutaneous, single dose) | Experimental | Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13 (subcutaneous, single dose) |
| Group B1 (hzVSF-v13 100mg, intravenous, multiple dose) | Experimental | Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. Receives: Drug: hzVSF-v13 (intravenous, multiple dose) |
| Group B2 (hzVSF-v13 400mg, intravenous, multiple dose) | Experimental | Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. Receives: Drug: hzVSF-v13 (intravenous, multiple dose) |
| Placebo (intravenous, single dose) | Placebo comparator | Single administration (intravenous) of placebo on Day 1. Receives: Drug: Placebo (intravenous, single dose) |
| Placebo (subcutaneous, single dose) | Placebo comparator | Single administration (subcutaneous) of placebo on Day 1. Receives: Drug: Placebo (subcutaneous, single dose) |
| Placebo (intravenous, multiple dose) | Placebo comparator | Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57. Receives: Drug: Placebo (intravenous, multiple dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline QTc interval at each time point
Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100~300Hz
Measured: 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 outcomes (2)
Pharmacokinetic - Cmax
Maximum observed Concentration of hzVSF-v13
Measured: 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-∞
Area under the plasma concentration-time curve (AUC) from time zero to infinity
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start16 Sep 2020
- Primary completion15 Jan 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuneMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- +61-8-70887900 Wabnitz, phD, Principal investigator, CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817202
- Sponsor's protocol ID
- hzVSF_v13-0002
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04817202
- Acronym / sponsor ID
- hzVSF_v13-0002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ImmuneMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A phase I, double-blind, placebo-controlled, single and multiple dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Group A1 (hzVSF-v13 50mg, intravenous, single dose) | Experimental | Drug: hzVSF-v13 (intravenous, single dose)Single administration (intravenous) of 50mg hzVSF-v13 on Day 1. |
| Group A2 (hzVSF-v13 100mg, intravenous, single dose) | Experimental | Drug: hzVSF-v13 (intravenous, single dose)Single administration (intravenous) of 100mg hzVSF-v13 on Day 1. |
| Group A3 (hzVSF-v13 200mg, intravenous, single dose) | Experimental | Drug: hzVSF-v13 (intravenous, single dose)Single administration (intravenous) of 200mg hzVSF-v13 on Day 1. |
| Group A4 (hzVSF-v13 400mg, intravenous, single dose) | Experimental | Drug: hzVSF-v13 (intravenous, single dose)Single administration (intravenous) of 400mg hzVSF-v13 on Day 1. |
| Group A5 (hzVSF-v13 800mg, intravenous, single dose) | Experimental | Drug: hzVSF-v13 (intravenous, single dose)Single administration (intravenous) of 800mg hzVSF-v13 on Day 1. |
| Group A6 (hzVSF-v13 1200mg, intravenous, single dose) | Experimental | Drug: hzVSF-v13 (intravenous, single dose)Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1. |
| Group A7 (hzVSF-v13 100mg, subcutaneous, single dose) | Experimental | Drug: hzVSF-v13 (subcutaneous, single dose)Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1. |
| Group B1 (hzVSF-v13 100mg, intravenous, multiple dose) | Experimental | Drug: hzVSF-v13 (intravenous, multiple dose)Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. |
| Group B2 (hzVSF-v13 400mg, intravenous, multiple dose) | Experimental | Drug: hzVSF-v13 (intravenous, multiple dose)Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. |
| Placebo (intravenous, single dose) | Placebo comparator | Drug: Placebo (intravenous, single dose)Single administration (intravenous) of placebo on Day 1. |
| Placebo (subcutaneous, single dose) | Placebo comparator | Drug: Placebo (subcutaneous, single dose)Single administration (subcutaneous) of placebo on Day 1. |
| Placebo (intravenous, multiple dose) | Placebo comparator | Drug: Placebo (intravenous, multiple dose)Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hzVSF-v13 (intravenous, single dose)Also: a humanized monoclonal antibody (mAb)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 | Group A1 (hzVSF-v13 50mg, intravenous, single dose), Group A2 (hzVSF-v13 100mg, intravenous, single dose), Group A3 (hzVSF-v13 200mg, intravenous, single dose), Group A4 (hzVSF-v13 400mg, intravenous, single dose), Group A5 (hzVSF-v13 800mg, intravenous, single dose), Group A6 (hzVSF-v13 1200mg, intravenous, single dose) |
| hzVSF-v13 (subcutaneous, single dose)Also: a humanized monoclonal antibody (mAb)Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration) | Drug | Group A7 (hzVSF-v13 100mg, subcutaneous, single dose) |
| hzVSF-v13 (intravenous, multiple dose)Also: a humanized monoclonal antibody (mAb)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 | Group B1 (hzVSF-v13 100mg, intravenous, multiple dose), Group B2 (hzVSF-v13 400mg, intravenous, multiple dose) |
| Placebo (intravenous, single dose)Also: 0.9% Normal salineDosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration) | Drug | Placebo (intravenous, single dose) |
| Placebo (subcutaneous, single dose)Also: 0.9% Normal salineDosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration) | Drug | Placebo (subcutaneous, single dose) |
| Placebo (intravenous, multiple dose)Also: 0.9% Normal salineDosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration) | Drug | Placebo (intravenous, multiple dose) |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
+61-8-70887900 Wabnitz, phD principal investigator
CMAX Clinical Research Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hzVSF-v13 (intravenous, single dose), hzVSF-v13 (subcutaneous, single dose) and hzVSF-v13 (intravenous, multiple dose) in people with Healthy Volunteers, run by ImmuneMed, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.