Clinical Trial: A Phase I Study to Assess the Safety APL-2 as an Add-On to Standard of Care in Subjects With PNH

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open Label, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL-2 as an Add-On to Standard of Care in Subjects With

Brief Summary: This study will be the initial exploration of APL-2 in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of APL-2 will guide decisions to further develop the drug.

Detailed Summary:
Sponsor: Apellis Pharmaceuticals, Inc.

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: Five months ]

Original Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: Four months ]

Current Secondary Outcome: PK Parameters [ Time Frame: Five months ]

Original Secondary Outcome: PK Parameters [ Time Frame: Four months ]

Information By: Apellis Pharmaceuticals, Inc.

Dates:
Date Received: October 8, 2014
Date Started: November 2014
Date Completion: December 2017
Last Updated: January 26, 2017
Last Verified: January 2017