First Safety Study in Humans of a Single Dose of CPG 52364

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

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-04-30

Brief Summary

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Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 1mg

Group Type EXPERIMENTAL

Placebo Comparator: Cohort 1 Placebo

Intervention Type DRUG

Drug: placebo for cohort 1 as single dose

52364 1 mg

Intervention Type DRUG

1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose

Cohort 2

Group Type EXPERIMENTAL

52364 3 mg

Intervention Type DRUG

3 mg capsule single dose administered orally as a single dose

Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo

Intervention Type DRUG

Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose

Cohort 3

Group Type EXPERIMENTAL

52364 10 mg

Intervention Type DRUG

Drug: 52364 30 mg capsule as a single dose

Cohort 4

Group Type EXPERIMENTAL

52364 30 mg

Intervention Type DRUG

Drug: 52364 30 mg capsule administered as a single dose

Cohort 5

Group Type EXPERIMENTAL

52364 100 mg

Intervention Type DRUG

Drug 52364 100 mg capsule administered as a single dose

Interventions

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Placebo Comparator: Cohort 1 Placebo

Drug: placebo for cohort 1 as single dose

Intervention Type DRUG

52364 3 mg

3 mg capsule single dose administered orally as a single dose

Intervention Type DRUG

Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo

Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose

Intervention Type DRUG

52364 10 mg

Drug: 52364 30 mg capsule as a single dose

Intervention Type DRUG

52364 30 mg

Drug: 52364 30 mg capsule administered as a single dose

Intervention Type DRUG

52364 100 mg

Drug 52364 100 mg capsule administered as a single dose

Intervention Type DRUG

52364 1 mg

1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal body mass index and weight
* No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

Exclusion Criteria

* Current illness or history of medical condition affecting the body's function
* Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
* Use of any medications during the study
* Positive TB test
* Smoking within 6 months
* Pregnancy or risk of Pregnancy
* Alcohol or drug misuse within 60 days
* Sensitivity to quinazolines

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes