Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

Phase 1

Completed

• Conditions: Cytomegalovirus Infections
• Interventions: Biological: TCN-202; Biological: Placebo

• Registration Number: NCT01594437
• Lead Sponsor: Theraclone Sciences, Inc.

Brief Summary

The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.

Detailed Description

Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is \~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Healthy adult volunteers
• Normal lab tests

Exclusion Criteria

• Prior treatment with monoclonal antibody

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCN-202	TCN-202	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number and severity of adverse events	60 days post infusion	Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).

Secondary Outcome Measures

Name	Time	Method
Peak serum concentration (Cmax) of TCN-202	1 day post infusion
Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)	60 days post infusion	Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies.
Area under the concentration time curve (AUC) of TCN-202	60 days post infusion
Time to maximum serum concentration (Tmax) of TCN-202	1 day post infusion

Trial Locations

Locations (1)

SNBL Clinical Pharmacology Center; 🇺🇸 Baltimore, Maryland, United States