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

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.
 
ClinicalTrials.gov Identifier: NCT02494024
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
C2N Diagnostics

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 10, 2015
Last Update Posted Date July 26, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Progressive Supranuclear Palsy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Single dose C2N-8E12 level 1
    Single IV infusion of C2N-8E12
    Intervention: Drug: Single dose C2N-8E12
  • Experimental: Single dose C2N-8E12 level 2
    Single IV infusion of C2N-8E12
    Intervention: Drug: Single dose C2N-8E12
  • Experimental: Single dose C2N-8E12 level 3
    Single IV infusion of C2N-8E12
    Intervention: Drug: Single dose C2N-8E12
  • Experimental: Single dose C2N-8E12 level 4
    Single IV infusion of C2N-8E12
    Intervention: Drug: Single dose C2N-8E12
  • Placebo Comparator: Single dose placebo
    Single IV infusion of placebo
    Intervention: Drug: Single dose placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02494024
Other Study ID Numbers  ICMJE C2N-8E12-WW-104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C2N Diagnostics
Study Sponsor  ICMJE C2N Diagnostics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Boxer, MD, PhD UCSF Memory and Aging Center
PRS Account C2N Diagnostics
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP