Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Placebo (intravenous, single dose)Drug: hzVSF-v13 (intravenous, single dose)Drug: hzVSF-v13 (intravenous, multiple dose)Drug: hzVSF-v13 (subcutaneous, single dose)Drug: Placebo (intravenous, multiple dose)Drug: Placebo (subcutaneous, single dose)
- Registration Number
- NCT04817202
- Lead Sponsor
- ImmuneMed, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo (intravenous, single dose) Placebo (intravenous, single dose) Single administration (intravenous) of placebo on Day 1. Group A5 (hzVSF-v13 800mg, intravenous, single dose) hzVSF-v13 (intravenous, single dose) Single administration (intravenous) of 800mg hzVSF-v13 on Day 1. Group B1 (hzVSF-v13 100mg, intravenous, multiple dose) hzVSF-v13 (intravenous, multiple dose) Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. Group A3 (hzVSF-v13 200mg, intravenous, single dose) hzVSF-v13 (intravenous, single dose) Single administration (intravenous) of 200mg hzVSF-v13 on Day 1. Group A6 (hzVSF-v13 1200mg, intravenous, single dose) hzVSF-v13 (intravenous, single dose) Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1. Group A7 (hzVSF-v13 100mg, subcutaneous, single dose) hzVSF-v13 (subcutaneous, single dose) Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1. Group B2 (hzVSF-v13 400mg, intravenous, multiple dose) hzVSF-v13 (intravenous, multiple dose) Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57. Placebo (intravenous, multiple dose) Placebo (intravenous, multiple dose) Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57. Group A2 (hzVSF-v13 100mg, intravenous, single dose) hzVSF-v13 (intravenous, single dose) Single administration (intravenous) of 100mg hzVSF-v13 on Day 1. Group A4 (hzVSF-v13 400mg, intravenous, single dose) hzVSF-v13 (intravenous, single dose) Single administration (intravenous) of 400mg hzVSF-v13 on Day 1. Group A1 (hzVSF-v13 50mg, intravenous, single dose) hzVSF-v13 (intravenous, single dose) Single administration (intravenous) of 50mg hzVSF-v13 on Day 1. Placebo (subcutaneous, single dose) Placebo (subcutaneous, single dose) Single administration (subcutaneous) of placebo on Day 1.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
CMAX, Clinical Research Pty Ltd.
🇦🇺Adelaide, South Australia, Australia