Overview

This trial is active, not recruiting.

Condition progressive supranuclear palsy
Treatments single dose c2n-8e12, single dose placebo
Phase phase 1
Sponsor C2N Diagnostics
Start date July 2015
End date August 2016
Trial size 32 participants
Trial identifier NCT02494024, C2N-8E12-WW-104

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Single IV infusion of C2N-8E12
single dose c2n-8e12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
(Experimental)
Single IV infusion of C2N-8E12
single dose c2n-8e12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
(Experimental)
Single IV infusion of C2N-8E12
single dose c2n-8e12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
(Experimental)
Single IV infusion of C2N-8E12
single dose c2n-8e12
C2N-8E12 is a humanized recombinant anti-human tau antibody.
(Placebo Comparator)
Single IV infusion of placebo
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.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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.

Additional Information

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
Principal investigator Adam Boxer, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by C2N Diagnostics.