drugset / Trial / NCT01885624

Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

NCT01885624 ↗

Phase 1 Completed 31 enrolled Theramab LLC
NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.

Timeline

Start
2011-11
Primary completion
2013-05
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject TGN-1412 Monoclonal antibody — Intravenous

Indications

No indication recorded.