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

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ClinicalTrials.gov Identifier: NCT03653208
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
ImmuneMed, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: hzVSF-v13 Drug: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Group 1

Drug: hzVSF-v13 10 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group 2

Drug: hzVSF-v13 20 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group 3

Drug: hzVSF-v13 50 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group 4

Drug: hzVSF-v13 100 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group5

Drug: hzVSF-v13 200 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group6

Drug: hzVSF-v13 400 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group 7

Drug: hzVSF-v13 800 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution

Experimental: Group 8

Drug: hzVSF-v13 1200 mg, IV administration

Drug: Placebo, IV administration

Drug: hzVSF-v13
  • Monoclonal Antibody IgG4
  • Product Formulation: 40 mg/mL hzVSF-v13 in 20 mM Histidine, 250 mM Sucrose, 0.02% Polysorbate 20, pH 5.8

Drug: Placebo
Normal saline solution




Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) of hzVSF-v13 [ 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) ]
    Cmax will be assessed after administration of single dose for pharmacokinetic properties of hzVSF-v13.

  2. Area under the concentration-time curve from time 0 to the last measurable time (AUClast) of hzVSF-v13 [ 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) ]
    AUClast will be assessed after administration of single dose for pharmacokinetic properties of hzVSF-v13.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653208


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
ImmuneMed, Inc.
Investigators
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Principal Investigator: In-Jin Jang, M.D Seoul National University College of Medicine/Seoul National University Hospital Department of Clinical Pharmacology and Therapeutics

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Responsible Party: ImmuneMed, Inc.
ClinicalTrials.gov Identifier: NCT03653208    
Other Study ID Numbers: IM_hzVSF_v13-0001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No