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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547014

52364-002

B1221001

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

61 participants in 5 patient groups

Cohort 1 1mg

Experimental group

Treatment:

Drug: 52364 1 mg

Drug: Placebo Comparator: Cohort 1 Placebo

Cohort 2

Experimental group

Treatment:

Drug: 52364 3 mg

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

Cohort 3

Experimental group

Treatment:

Drug: 52364 10 mg

Cohort 4

Experimental group

Treatment:

Drug: 52364 30 mg

Cohort 5

Experimental group

Treatment:

Drug: 52364 100 mg