A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers

Summary

The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14 consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label, continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to 9000 mcg/day of ITF2984.

Timeline

Start

2013-05

Primary completion

2013-09

Completion

2013-12

Drugs

Indications

No indication recorded.