Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)

NCT04817202 | Completed Phase 1

• 1 other identifier: hzVSF_v13-0002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Changes from baseline QTc interval at each time point

  Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100\~300Hz

  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

  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-∞

  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

Study Arms (12)

Group A1 (hzVSF-v13 50mg, intravenous, single dose)

EXPERIMENTAL

Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: hzVSF-v13 (intravenous, multiple dose)

Placebo (intravenous, single dose)

PLACEBO COMPARATOR

Single administration (intravenous) of placebo on Day 1.

Drug: Placebo (intravenous, single dose)

Placebo (subcutaneous, single dose)

PLACEBO COMPARATOR

Single administration (subcutaneous) of placebo on Day 1.

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.

Drug: Placebo (intravenous, multiple dose)

Interventions

hzVSF-v13 (intravenous, single dose) DRUG

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)

Also known as: a humanized monoclonal antibody (mAb)

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) DRUG

Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)

Also known as: a humanized monoclonal antibody (mAb)

Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)

hzVSF-v13 (intravenous, multiple dose) DRUG

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)

Also known as: a humanized monoclonal antibody (mAb)

Group B1 (hzVSF-v13 100mg, intravenous, multiple dose); Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)

Placebo (intravenous, single dose) DRUG

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

Also known as: 0.9% Normal saline

Placebo (intravenous, single dose)

Placebo (subcutaneous, single dose) DRUG

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

Also known as: 0.9% Normal saline

Placebo (subcutaneous, single dose)

Placebo (intravenous, multiple dose) DRUG

Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)

Also known as: 0.9% Normal saline

Placebo (intravenous, multiple dose)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (1)

CMAX, Clinical Research Pty Ltd.

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Interventions

Injections, Subcutaneous; Saline Solution

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• +61-8-70887900 Wabnitz, phD

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

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: March 22, 2021
• First Posted: March 26, 2021
• Study Start: September 16, 2020
• Primary Completion: January 15, 2022
• Study Completion: July 7, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)