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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: hzVSF-v13
Drug: Placebo

Registration Number: NCT03653208

Lead Sponsor: 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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 4 (hzVSF-v13 100mg)	hzVSF-v13	Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
Group 1 (hzVSF-v13 10mg)	hzVSF-v13	Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
Group 6 (hzVSF-v13 400mg)	hzVSF-v13	Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
Group 8 (hzVSF-v13 1200mg)	hzVSF-v13	Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
Placebo	Placebo	Placebo group received a single placebo on Day 1.
Group 2 (hzVSF-v13 20mg)	hzVSF-v13	Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
Group 3 (hzVSF-v13 50mg)	hzVSF-v13	Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
Group 5 (hzVSF-v13 200mg)	hzVSF-v13	Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
Group 7 (hzVSF-v13 800mg)	hzVSF-v13	Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessments by Vital Signs	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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Characteristics - Cmax (Concentration Maximum)	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)	Maximum observed Concentration of hzVSF-v13 from Day1 to Day92.
PK - AUClast (Area Under the Curve Last)	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)	Area under the plasma concentration from Day1 to time of last measurable concentration.