Healthy Volunteers
Conditions
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.
Detailed description
A phase I, double-blind, placebo-controlled, single and multiple dose
Interventions
DRUGhzVSF-v13 (intravenous, single dose)
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)
DRUGhzVSF-v13 (subcutaneous, single dose)
Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
DRUGhzVSF-v13 (intravenous, multiple dose)
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)
DRUGPlacebo (intravenous, single dose)
Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)
DRUGPlacebo (subcutaneous, single dose)
Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
DRUGPlacebo (intravenous, multiple dose)
Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
Sponsors
ImmuneMed, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline QTc interval at each time point | 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 | Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100\ 300Hz |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Maximum observed Concentration of hzVSF-v13 |
| 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 | Area under the plasma concentration-time curve (AUC) from time zero to infinity |
Countries
Australia
Outcome results
None listed