Clinical Trial: A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Double-Blind, Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 (Recombinant Fully Human Antibody Inhibitor of Plasma Kallikrein) in Healthy Subject

Brief Summary: The purpose of this study is to assess the safety and tolerability of the study drug (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to receive DX-2930 or placebo.

Detailed Summary: Approximately 32 healthy subjects will be randomized to receive DX-2930 or placebo.
Sponsor: Shire

Current Primary Outcome: Proportion of subjects with adverse events [ Time Frame: 112 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: DX-2930 plasma level [ Time Frame: 112 days ]

Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: August 8, 2013
Date Started: August 2013
Date Completion:
Last Updated: April 29, 2016
Last Verified: April 2016