Clinical Trial: Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Pal
Brief Summary: This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with progressive supranuclear palsy (PSP).
Detailed Summary: This study evaluates the safety, tolerability, pharmacokinetics, and maximum tolerated dose (within dosing range) of intravenous (IV) infusion of C2N-8E12 in 32 patients with progressive supranuclear palsy (PSP). Four sequential cohorts will receive increasing single doses of either C2N-8E12 or placebo. Out of every 4 patients enrolled 3 patients will receive drug and 1 will receive placebo. Study participants will be followed for a minimum of 2 months post-treatment to monitor for the safety, tolerability, pharmacokinetics, and immunogenicity of C2N-8E12.
Sponsor: C2N Diagnostics
Current Primary Outcome: Safety and tolerability, as measured by number of participants experiencing adverse events (AEs), serious AEs, and abnormalities in clinical laboratory tests, vital signs, ECGs, MRI, and physical and neurological exams. [ Time Frame: up to 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Immunogenicity as measured by the number of participants developing anti drug antibodies. [ Time Frame: up to 4 months ]
- Area under the concentration vs time curve (AUC) of C2N-8E12 [ Time Frame: up to 4 months ]
- Elimination half-life of C2N-8E12 [ Time Frame: up to 4 months ]
Original Secondary Outcome: Same as current
Information By: C2N Diagnostics
Dates:
Date Received: June 30, 2015
Date Started: July 2015
Date Completion: August 2016
Last Updated: July 25, 2016
Last Verified: July 2016