HealthyPhase 1NCT03653208

Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers

A Phase 1 study testing hzVSF-v13 in people with Healthy, run by ImmuneMed, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate the safety/tolerability and pharmacokinetic characteristics after single intravenous (IV) administration of hzVSF-v13 (humanized Virus Suppressing Factor-variant 13) in healthy male volunteers Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: hzVSF-v13
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteSouth Korea
Study dates: 20 Nov 2018to 29 Feb 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Who cannot join

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out "positive" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec

Show all 18Show fewer

Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

About this study

Official title: Dose Blocked-randomized, Double-blind, Placebo Controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 After Intravenous Administration in Healthy Male Volunteers

Read the detailed description

Dose blocked-randomized, double-blind, placebo controlled, single dose, dose-escalation study to investigate the safety/tolerability and pharmacokinetic characteristics of hzVSF-v13 after IV administration in healthy male volunteers

Conditions: Healthy
Being tested: hzVSF-v13, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hzVSF-v13Drug
Also called a humanized monoclonal antibody (mAb)
Dosage form: 10mg / 20mg / 50mg / 100mg / 200mg / 400mg / 800mg / 1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1 (single administration)
PlaceboDrug
Also called 0.9% Normal saline
Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)

Study groups in NCT03653208
Study group	Role	What they receive
Group 1 (hzVSF-v13 10mg)	Experimental	Group 1 received a single 10mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 2 (hzVSF-v13 20mg)	Experimental	Group 2 received a single 20mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 3 (hzVSF-v13 50mg)	Experimental	Group 3 received a single 50mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 4 (hzVSF-v13 100mg)	Experimental	Group 4 received a single 100mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 5 (hzVSF-v13 200mg)	Experimental	Group 5 received a single 200mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 6 (hzVSF-v13 400mg)	Experimental	Group 6 received a single 400mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 7 (hzVSF-v13 800mg)	Experimental	Group 7 received a single 800mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Group 8 (hzVSF-v13 1200mg)	Experimental	Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1. Receives: Drug: hzVSF-v13
Placebo	Placebo comparator	Placebo group received a single placebo on Day 1. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability Assessments by Vital Signs
Systolic Blood Pressure: ≤ 90 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 140 mmHg and increase from baseline ≥ 20 mmHg Diastolic Blood Pressure: ≤ 50 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 90 mmHg and increase from baseline ≥ 10 mmHg Heart Rate: ≤ 40 beats/min and decrease from baseline ≥ 20 beats/min, ≥ 100 beats/min and increase from baseline ≥ 20 beats/min
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)

Secondary outcomes (2)

Pharmacokinetic Characteristics - Cmax (Concentration Maximum)
Maximum observed Concentration of hzVSF-v13 from Day1 to Day92.
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
PK - AUClast (Area Under the Curve Last)
Area under the plasma concentration from Day1 to time of last measurable concentration.
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201829 Feb 2020

First posted31 Aug 2018
Study start20 Nov 2018
Primary completion29 Feb 2020
Study completion29 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03653208
Sponsor's protocol ID: IM_hzVSF_v13-0001
Status last verified: Dec 2020
First submitted: 21 Aug 2018
Last updated: 27 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Blocked-randomized, Double-blind, Placebo Controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 After Intravenous Administration in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03653208
Acronym / sponsor ID: IM_hzVSF_v13-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: ImmuneMed, Inc.Industry (pharma, biotech, devices)
Study start: 20 Nov 2018 (actual)
Primary completion: 29 Feb 2020 (actual)
Study completion: 29 Feb 2020 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 2 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
Group 1 (hzVSF-v13 10mg)	Experimental	Drug: hzVSF-v13Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
Group 2 (hzVSF-v13 20mg)	Experimental	Drug: hzVSF-v13Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
Group 3 (hzVSF-v13 50mg)	Experimental	Drug: hzVSF-v13Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
Group 4 (hzVSF-v13 100mg)	Experimental	Drug: hzVSF-v13Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
Group 5 (hzVSF-v13 200mg)	Experimental	Drug: hzVSF-v13Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
Group 6 (hzVSF-v13 400mg)	Experimental	Drug: hzVSF-v13Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
Group 7 (hzVSF-v13 800mg)	Experimental	Drug: hzVSF-v13Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
Group 8 (hzVSF-v13 1200mg)	Experimental	Drug: hzVSF-v13Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
Placebo	Placebo comparator	Drug: PlaceboPlacebo group received a single placebo on Day 1.

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Key exclusion criteria (18 listed)

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out "positive" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm

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-v13Also: a humanized monoclonal antibody (mAb)Dosage form: 10mg / 20mg / 50mg / 100mg / 200mg / 400mg / 800mg / 1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1 (single administration)	Drug	Group 1 (hzVSF-v13 10mg), Group 2 (hzVSF-v13 20mg), Group 3 (hzVSF-v13 50mg), Group 4 (hzVSF-v13 100mg), Group 5 (hzVSF-v13 200mg), Group 6 (hzVSF-v13 400mg), Group 7 (hzVSF-v13 800mg), Group 8 (hzVSF-v13 1200mg)
PlaceboAlso: 0.9% Normal salineDosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)	Drug	Placebo

Primary outcome

Safety and Tolerability Assessments by Vital Signs
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
Systolic Blood Pressure: ≤ 90 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 140 mmHg and increase from baseline ≥ 20 mmHg Diastolic Blood Pressure: ≤ 50 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 90 mmHg and increase from baseline ≥ 10 mmHg Heart Rate: ≤ 40 beats/min and decrease from baseline ≥ 20 beats/min, ≥ 100 beats/min and increase from baseline ≥ 20 beats/min

2 secondary outcomes

Pharmacokinetic Characteristics - Cmax (Concentration Maximum)
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
PK - AUClast (Area Under the Curve Last)
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (hzVSF-v13 10mg)	3	3
Group 2 (hzVSF-v13 20mg)	3	3
Group 3 (hzVSF-v13 50mg)	6	6
Group 4 (hzVSF-v13 100mg)	6	6
Group 5 (hzVSF-v13 200mg)	6	5
Group 6 (hzVSF-v13 400mg)	6	6
Group 7 (hzVSF-v13 800mg)	6	6
Group 8 (hzVSF-v13 1200mg)	6	5
Placebo	14	13

Primary outcome: Safety and Tolerability Assessments by Vital Signs

Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose). Count of participants. Unit: Participants

Measure	Group 1 (hzVSF-v13 10mg) n = 3	Group 2 (hzVSF-v13 20mg) n = 3	Group 3 (hzVSF-v13 50mg) n = 6	Group 4 (hzVSF-v13 100mg) n = 6	Group 5 (hzVSF-v13 200mg) n = 6	Group 6 (hzVSF-v13 400mg) n = 6	Group 7 (hzVSF-v13 800mg) n = 6	Group 8 (hzVSF-v13 1200mg) n = 6	Placebo n = 13
Value	3	3	6	6	6	6	6	6	13

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 92 Days after dosing date (Day1).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (hzVSF-v13 10mg)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Group 2 (hzVSF-v13 20mg)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Group 3 (hzVSF-v13 50mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 4 (hzVSF-v13 100mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 5 (hzVSF-v13 200mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 6 (hzVSF-v13 400mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 7 (hzVSF-v13 800mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 8 (hzVSF-v13 1200mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Placebo	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

In-Jin Jang, M.D principal investigator

Seoul National University College of Medicine/Seoul National University Hospital Department of Clinical Pharmacology and Therapeutics

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 in people with Healthy, run by ImmuneMed, Inc. at 1 site in South Korea.

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 5 inclusion and 18 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 27 Apr 2021. 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 South Korea. 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?

Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Tolerability Assessments by Vital Signs (time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03653208.

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 27 Apr 2021.