drugset / Trial / NCT03643627

A Study of SYNT001 in Healthy Volunteers

NCT03643627 ↗

Phase 0 Completed 31 enrolled Syntimmune, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001.

Timeline

Start
2016-08-17
Primary completion
2017-04-13
Completion
2017-04-13

Drugs

EvaluationDrugModalityDoseRoute
Subject ORILANOLIMAB Monoclonal antibody 1 mg/kg Intravenous
Subject ORILANOLIMAB Monoclonal antibody 3 mg/kg Intravenous
Subject ORILANOLIMAB Monoclonal antibody 10 mg/kg Intravenous
Subject ORILANOLIMAB Monoclonal antibody 30 mg/kg Intravenous

Indications

No indication recorded.