drugset / Trial / NCT02649270

Tolerability, Safety and Pharmacokinetic Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese Psoriasis

NCT02649270

Phase 1 Terminated 11 enrolled Biotech Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for psoriasis in India. The first trial in China is to evaluate the tolerability, safety, pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with psoriasis.

Timeline

Start
2014-10
Primary completion
2015-06
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Itolizumab Monoclonal antibody 0.2 mg/kg Intravenous
Subject Itolizumab Monoclonal antibody 0.4 mg/kg Intravenous
Subject Itolizumab Monoclonal antibody 0.8 mg/kg Intravenous
Subject Itolizumab Monoclonal antibody 1.6 mg/kg Intravenous

Indications