Brief Title
Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
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 Palsy
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 Description
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 Phase
Phase 1
Study Type
Interventional
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.
Secondary Outcome
Immunogenicity as measured by the number of participants developing anti drug antibodies.
Condition
Progressive Supranuclear Palsy
Intervention
Single dose C2N-8E12
Study Arms / Comparison Groups
Single dose C2N-8E12 level 1
Description: Single IV infusion of C2N-8E12
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
32
Start Date
July 2015
Completion Date
August 2016
Primary Completion Date
August 2016
Eligibility 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.
Gender
All
Ages
50 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Adam Boxer, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02494024
Organization ID
C2N-8E12-WW-104
Responsible Party
Sponsor
Study Sponsor
C2N Diagnostics
Study Sponsor
Adam Boxer, MD, PhD, Principal Investigator, UCSF Memory and Aging Center
Verification Date
July 2017