drugset
drugset / Trial / NCT02800811

Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104

NCT02800811 ↗

Phase 1 Completed 64 enrolled OSE Immunotherapeutics
RandomizedParallel-groupTriple-blindTreatment

Summary

First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.

Timeline

Start
2015-04
Primary completion
2016-06
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject pegrizeprument Monoclonal antibody 0.005 mg/kg Intravenous
Subject pegrizeprument Monoclonal antibody 0.02 mg/kg Intravenous
Subject pegrizeprument Monoclonal antibody 0.05 mg/kg Intravenous
Subject pegrizeprument Monoclonal antibody 0.2 mg/kg Intravenous
Subject pegrizeprument Monoclonal antibody 0.5 mg/kg Intravenous
Subject pegrizeprument Monoclonal antibody 1.5 mg/kg Intravenous

Indications

disease related to transplantation rheumatoid arthritis