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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547014

Enrollment

Registered

2007-10-19

Start date

2007-09-30

Completion date

2008-04-30

Last updated

2009-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)

Brief summary

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.

Interventions

DRUGPlacebo Comparator: Cohort 1 Placebo

Drug: placebo for cohort 1 as single dose

DRUG52364 3 mg

3 mg capsule single dose administered orally as a single dose

DRUGPlacebo 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

DRUG52364 10 mg

Drug: 52364 30 mg capsule as a single dose

DRUG52364 30 mg

Drug: 52364 30 mg capsule administered as a single dose

DRUG52364 100 mg

Drug 52364 100 mg capsule administered as a single dose

DRUG52364 1 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Clinical Assessment of Adverse Events	28 days/subject

Secondary

Measure	Time frame
Pharmacokinetic Parameters	28 days/subject

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026