Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: C2N Diagnostics

Criteria

Key Inclusion Criteria:

• Meets NINDS-SPSP possible or probable criteria as modified for NNIPPS and AL-108-231 clinical trials

• Brain MRI at Screening is consistent with PSP;

• Stable medications for Parkinsonism for at least 2 months prior to Screening;

• Agree to use protocol specified methods of contraception.

Key Exclusion Criteria:

• Signs of a progressive neurological disorder that better meets the criteria for types of neurological disorders other than PSP;

• Currently on any other biologic or immunomodulatory therapy;

• Subjects that reside at a skilled nursing or dementia care facility;

• Diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits;

• Untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale;

• Unable to tolerate MRI scan at Screening or any other contraindication to MRI;

• Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications.