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

Study Overview
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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.

Official Title
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Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Placebo Comparator: Cohort 1 Placebo
* Drug: 52364 3 mg
* Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
* Drug: 52364 10 mg
* Drug: 52364 30 mg
* Drug: 52364 100 mg
* Drug: 52364 1 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 1mg<br> | Drug: Placebo Comparator: Cohort 1 Placebo<br>* Drug: placebo for cohort 1 as single dose<br>Drug: 52364 1 mg<br>* 1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose<br>|
| Experimental: Cohort 2<br> | Drug: 52364 3 mg<br>* 3 mg capsule single dose administered orally as a single dose<br>Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo<br>* Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose<br>|
| Experimental: Cohort 3<br> | Drug: 52364 10 mg<br>* Drug: 52364 30 mg capsule as a single dose<br>|
| Experimental: Cohort 4<br> | Drug: 52364 30 mg<br>* Drug: 52364 30 mg capsule administered as a single dose<br>|
| Experimental: Cohort 5<br> | Drug: 52364 100 mg<br>* Drug 52364 100 mg capsule administered as a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Assessment of Adverse Events |  | 28 days/subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameters |  | 28 days/subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)