CompletedPhase 1

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

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

Lead sponsor

C2N Diagnostics

Asset

C2N-8E12

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Frontotemporal dementia

Key I/E criteria

•Age 50-85•MRI contraindications excluded

Primary endpoint

•Safety and tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDC2N-8E12-WW-104

NCT IDNCT02494024

Timeline

Milestones

Study start2015-07 (month precision)

Study first posted2015-07-10estimated

Primary completion2016-08actual (month precision)

Study completion2016-08actual (month precision)

Last update posted2017-07-26actual

Assets

Drug assets

C2N-8E12

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Neuroimaging

1 endpoint

Primary/protocol endpoint

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

event count, event

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Immunogenicity as measured by the number of participants developing anti drug antibodies.

Time frame:up to 4 months

event count, event

Secondary/protocol endpoint

Area under the concentration vs time curve (AUC) of C2N-8E12

Time frame:up to 4 months

concentration, descriptive

Secondary/protocol endpoint

Elimination half-life of C2N-8E12

Time frame:up to 4 months

concentration, descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.