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

July 25, 2017 updated by: C2N Diagnostics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles (UCLA)
      • San Diego, California, United States, 92037
        • UCSD Department of Neurosciences
      • San Francisco, California, United States, 94158
        • University of California, San Francisco
    • Florida
      • Gainesville, Florida, United States, 32607
        • University of Florida College of Medicine
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10032-3795
        • Columbia University
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2551
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Health Presbyterian Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity as measured by the number of participants developing anti drug antibodies.
Time Frame: up to 4 months
up to 4 months
Area under the concentration vs time curve (AUC) of C2N-8E12
Time Frame: up to 4 months
up to 4 months
Elimination half-life of C2N-8E12
Time Frame: up to 4 months
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C2N Diagnostics

Investigators

  • Principal Investigator: Adam Boxer, MD, PhD, UCSF Memory and Aging Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2N-8E12-WW-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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