Trial | NCT02494024  Report issue

Title

Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
A Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    abbv-8e12 ...

  • Study Participants

    32
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).
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.
Study Started
Jul 31
2015
Primary Completion
Aug 31
2016
Study Completion
Aug 31
2016
Last Update
Jul 26
2017

Drug Single dose C2N-8E12

C2N-8E12 is a humanized recombinant anti-human tau antibody.

Drug Single dose placebo

Subjects will be block randomized to receive a single dose of C2N-8E12 or placebo in two blocks of 4 subjects (3:1, C2N-8E12:placebo) per cohort.

Single dose C2N-8E12 level 1 Experimental

Single IV infusion of C2N-8E12

Single dose C2N-8E12 level 2 Experimental

Single IV infusion of C2N-8E12

Single dose C2N-8E12 level 3 Experimental

Single IV infusion of C2N-8E12

Single dose C2N-8E12 level 4 Experimental

Single IV infusion of C2N-8E12

Single dose placebo Placebo Comparator

Single IV infusion of placebo

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.
No Results Posted