CTS

CompletedPhase 1

Safety Study of CTS21166 to Treat Alzheimer Disease

A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males

Lead sponsor

CoMentis

Asset

CTS21166 (ZPQ-21166)

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age ≥22•Male

Primary endpoint

•Safety and tolerability of single ascending doses of CTS21166 following

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 IDCTS21166-101

NCT IDNCT00621010

Timeline

Milestones

Study start2007-06 (month precision)

Primary completion2008-02actual (month precision)

Study completion2008-02actual (month precision)

Study first posted2008-02-22estimated

Last update posted2008-07-09estimated

Assets

Drug assets

CTS21166 (ZPQ-21166)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age22 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Healthy adult male > age 21;

•non-smoker (minimum 6 months)

Exclusion criteria

•History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease

•History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;

•Participation in another clinical trial within 30 days prior to dosing

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration

ratio, event

Secondary/protocol endpoint

To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma

descriptive

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.