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Safety Study of CTS21166 to Treat Alzheimer Disease

NCT ID: NCT00621010

Last Updated: 2008-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Cohort

Group Type EXPERIMENTAL

CTS21166 (ZPQ-21166)

Intervention Type 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

Interventions

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CTS21166 (ZPQ-21166)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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CoMentis

INDUSTRY

Sponsor Role lead

Responsible Party

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Comentis, Inc.

Principal Investigators

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Henry Hsu, M.D.

Role: STUDY_DIRECTOR

CoMentis

Locations

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Lifetree Clinical Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CTS21166-101

Identifier Type: -

Identifier Source: org_study_id