Safety Study of CTS21166 to Treat Alzheimer Disease

Phase 1CompletedNCT00621010

CoMentis56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Alzheimer's Disease

Interventions

CTS21166 (ZPQ-21166)DRUG

Cohort 1: (7.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 2: (22.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 3: (45 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 4: (90 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 5: (150 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 6: (225 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days,proceed to Part B. Cohort 7: (225 mg): Up to 10 subjects, open label, 3 hour infusion

Eligibility

Sex: MALEMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lifetree Clinical Research

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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