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

C2N Diagnostics32 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Progressive Supranuclear Palsy

Interventions

Single dose C2N-8E12DRUG

C2N-8E12 is a humanized recombinant anti-human tau antibody.

Single dose placeboDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (12)

University of Alabama

Birmingham, Alabama, United States

Mayo Clinic

Scottsdale, Arizona, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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