drugset
drugset / Trial / NCT01858935

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy Subjects

NCT01858935 ↗

Phase 1 Completed 56 enrolled Bristol-Myers Squibb Nitto Denko Corporation · collab
RandomizedSingle-groupTriple-blindOther

Summary

This study is to evaluate the safety, tolerability, and pharmacokinetics of ND-L02-s0201 in normal, healthy, subjects

Timeline

Start
2013-05
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.03 mg/kg Intravenous
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.1 mg/kg Intravenous
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.2 mg/kg Intravenous
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.4 mg/kg Intravenous
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.5 mg/kg Intravenous
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.6 mg/kg Intravenous
Subject ND-L02-s0201 Small interfering RNA (siRNA) 0.8 mg/kg Intravenous

Indications

No indication recorded.