Safety Study of CTS21166 to Treat Alzheimer Disease

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: CTS21166 (ZPQ-21166)

• Registration Number: NCT00621010
• Lead Sponsor: CoMentis

Brief Summary

This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-22
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-07
• Last Update Posted: 2008-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	CTS21166 (ZPQ-21166)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lifetree Clinical Research; 🇺🇸 Salt Lake City, Utah, United States