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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02494024
• Date of registration: 30/06/2015
• Prospective Registration: Yes
• Primary sponsor: C2N Diagnostics
• Public title: Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
• Scientific 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
• Date of first enrolment: July 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02494024
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Adam Boxer, MD, PhD
• Affiliation: UCSF Memory and Aging Center

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy

Intervention(s)

Drug: Single dose C2N-8E12

Drug: Single dose placebo

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

C2N-8E12-WW-104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors