drugset / Trial / NCT03653208

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

NCT03653208

Phase 1 Completed 56 enrolled ImmuneMed, Inc.
RandomizedSequentialQuadruple-blindTreatment

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

Timeline

Start
2018-11-20
Primary completion
2020-02-29
Completion
2020-02-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Burfiralimab Monoclonal antibody 10 mg Intravenous
Subject Burfiralimab Monoclonal antibody 20 mg Intravenous
Subject Burfiralimab Monoclonal antibody 50 mg Intravenous
Subject Burfiralimab Monoclonal antibody 100 mg Intravenous
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.