drugset / Trial / NCT04817202

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

NCT04817202

Phase 1 Completed 72 enrolled ImmuneMed, Inc.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2020-09-16
Primary completion
2022-01-15
Completion
2022-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Burfiralimab Monoclonal antibody 50 mg Intravenous
Subject Burfiralimab Monoclonal antibody 100 mg Intravenous
Subject Burfiralimab Monoclonal antibody 100 mg Subcutaneous
Subject Burfiralimab Monoclonal antibody 200 mg Intravenous
Subject Burfiralimab Monoclonal antibody 400 mg Intravenous
Subject Burfiralimab Monoclonal antibody 800 mg Intravenous
Subject Burfiralimab Monoclonal antibody 1200 mg Intravenous

Indications

No indication recorded.