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drugset / Trial / NCT01335165

Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

NCT01335165 ↗

Phase 1 Terminated 10 enrolled Alexion Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this research study is to understand the safety, pharmacokinetics and pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV (through a vein) or SC (under the skin) to patients with PNH.

Timeline

Start
2011-04
Primary completion
2014-03
Completion
2014-03

Outcome

Outcome not reported

Stopped (Enrollment): “Inability to reach enrollment as planned”

Drugs

EvaluationDrugModalityDoseRoute
Subject ALXN1102 Unknown 0.1 mg/kg Intravenous
Subject ALXN1102 Unknown 0.3 mg/kg Intravenous
Subject ALXN1102 Unknown 1 mg/kg Intravenous
Subject ALXN1103 Unknown 1 mg/kg Intravenous
Subject ALXN1103 Unknown 3 mg/kg Intravenous
Subject ALXN1103 Unknown 6 mg/kg Intravenous
Subject ALXN1103 Unknown 10 mg/kg Intravenous

Indications

paroxysmal nocturnal hemoglobinuria