Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia

Phase 1 Terminated 24 enrolled Sideris Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.

Timeline

Start: 2014-10
Primary completion: 2015-09
Completion: 2015-09

Outcome

Outcome not reported

Stopped: “Changes in renal function parameters.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SP-420	Small molecule	1.5 mg/kg	—
Subject	SP-420	Small molecule	3 mg/kg	—
Subject	SP-420	Small molecule	6 mg/kg	—
Subject	SP-420	Small molecule	9 mg/kg	—
Subject	SP-420	Small molecule	12 mg/kg	—
Subject	SP-420	Small molecule	24 mg/kg	—

Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia

Summary

Timeline

Outcome

Drugs

Indications