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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02494024
First Posted: July 10, 2015
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C2N Diagnostics
  Purpose
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).

Condition Intervention Phase
Progressive Supranuclear Palsy Drug: Single dose C2N-8E12 Drug: Single dose placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by C2N Diagnostics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: July 2015
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
C2N Diagnostics
Investigators
Principal Investigator: Adam Boxer, MD, PhD UCSF Memory and Aging Center
  More Information

Publications:
Responsible Party: C2N Diagnostics
ClinicalTrials.gov Identifier: NCT02494024     History of Changes
Other Study ID Numbers: C2N-8E12-WW-104
First Submitted: June 30, 2015
First Posted: July 10, 2015
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by C2N Diagnostics:
PSP
C2N-8E12
tauopathy
Progressive Supranuclear Palsy
Steele Richardson Olszewski Syndrome
Humanized anti-tau antibody

Additional relevant MeSH terms:
Paralysis
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases