Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
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ClinicalTrials.gov Identifier: NCT02494024 |
Recruitment Status :
Completed
First Posted : July 10, 2015
Last Update Posted : July 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Progressive Supranuclear Palsy | Drug: Single dose C2N-8E12 Drug: Single dose placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2015 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Single dose C2N-8E12 level 1
Single IV infusion of C2N-8E12
|
Drug: Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody. |
Experimental: Single dose C2N-8E12 level 2
Single IV infusion of C2N-8E12
|
Drug: Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody. |
Experimental: Single dose C2N-8E12 level 3
Single IV infusion of C2N-8E12
|
Drug: Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody. |
Experimental: Single dose C2N-8E12 level 4
Single IV infusion of C2N-8E12
|
Drug: Single dose C2N-8E12
C2N-8E12 is a humanized recombinant anti-human tau antibody. |
Placebo Comparator: Single dose placebo
Single IV infusion of placebo
|
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. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494024
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35294 | |
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
University of California, Los Angeles (UCLA) | |
Los Angeles, California, United States, 90095 | |
UCSD Department of Neurosciences | |
San Diego, California, United States, 92037 | |
University of California, San Francisco | |
San Francisco, California, United States, 94158 | |
United States, Florida | |
University of Florida College of Medicine | |
Gainesville, Florida, United States, 32607 | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Indiana | |
Indiana University Medical Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032-3795 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-2551 | |
United States, Texas | |
Texas Health Presbyterian Dallas | |
Dallas, Texas, United States, 75231 |
Principal Investigator: | Adam Boxer, MD, PhD | UCSF Memory and Aging Center |
Responsible Party: | C2N Diagnostics |
ClinicalTrials.gov Identifier: | NCT02494024 |
Other Study ID Numbers: |
C2N-8E12-WW-104 |
First Posted: | July 10, 2015 Key Record Dates |
Last Update Posted: | July 26, 2017 |
Last Verified: | July 2017 |
PSP C2N-8E12 tauopathy |
Progressive Supranuclear Palsy Steele Richardson Olszewski Syndrome Humanized anti-tau antibody |
Paralysis Supranuclear Palsy, Progressive Neurologic Manifestations Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Movement Disorders Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Neurodegenerative Diseases Eye Diseases |