Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
- Conditions
- Progressive Supranuclear Palsy
- Interventions
- Drug: Single dose C2N-8E12Drug: Single dose placebo
- Registration Number
- NCT02494024
- Lead Sponsor
- C2N Diagnostics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single dose C2N-8E12 level 1 Single dose C2N-8E12 Single IV infusion of C2N-8E12 Single dose C2N-8E12 level 2 Single dose C2N-8E12 Single IV infusion of C2N-8E12 Single dose C2N-8E12 level 3 Single dose C2N-8E12 Single IV infusion of C2N-8E12 Single dose C2N-8E12 level 4 Single dose C2N-8E12 Single IV infusion of C2N-8E12 Single dose placebo Single dose placebo Single IV infusion of placebo
- Primary Outcome Measures
Name Time Method 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. up to 4 months
- Secondary Outcome Measures
Name Time Method Immunogenicity as measured by the number of participants developing anti drug antibodies. up to 4 months Area under the concentration vs time curve (AUC) of C2N-8E12 up to 4 months Elimination half-life of C2N-8E12 up to 4 months
Trial Locations
- Locations (10)
University of California, San Francisco
🇺🇸San Francisco, California, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
UCSD Department of Neurosciences
🇺🇸San Diego, California, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Texas Health Presbyterian Dallas
🇺🇸Dallas, Texas, United States
Columbia University
🇺🇸New York, New York, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States