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

NCT03653208 | Completed Phase 1 Results

• 1 other identifier: IM_hzVSF_v13-0001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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)

Study Arms (9)

Group 1 (hzVSF-v13 10mg)

EXPERIMENTAL

Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 2 (hzVSF-v13 20mg)

EXPERIMENTAL

Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 3 (hzVSF-v13 50mg)

EXPERIMENTAL

Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 4 (hzVSF-v13 100mg)

EXPERIMENTAL

Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 5 (hzVSF-v13 200mg)

EXPERIMENTAL

Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 6 (hzVSF-v13 400mg)

EXPERIMENTAL

Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 7 (hzVSF-v13 800mg)

EXPERIMENTAL

Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Group 8 (hzVSF-v13 1200mg)

EXPERIMENTAL

Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.

Drug: hzVSF-v13

Placebo

PLACEBO COMPARATOR

Placebo group received a single placebo on Day 1.

Drug: Placebo

Interventions

hzVSF-v13 DRUG

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)

Also known as: a humanized monoclonal antibody (mAb)

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)

Placebo DRUG

Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)

Also known as: 0.9% Normal saline

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Byoungok Ahn
• Organization: ImmuneMed Inc.

ahnbo@immunemed.co.kr

+82-2-527-8391

Study Officials

• In-Jin Jang, M.D

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 31, 2018
• Study Start: November 20, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: April 27, 2021
• Results First Posted: April 2, 2021

Record last verified: 2020-12

Locations

KR (1)