Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

Cytomegalovirus Infections Clinical Trial

Official title:

Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594437
• Other study ID #: TCN-202-001
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2012
• Last updated: March 19, 2014
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Theraclone Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy adult volunteers

• Normal lab tests

Exclusion Criteria:

• Prior treatment with monoclonal antibody

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infections

Intervention

Biological:
• TCN-202
Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.
• Placebo
One or two doses administered by intravenous infusion.

Locations

Country	Name	City	State
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Theraclone Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of adverse events	Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).	60 days post infusion	Yes
Secondary	Peak serum concentration (Cmax) of TCN-202		1 day post infusion	No
Secondary	Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)	Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies.	60 days post infusion	No
Secondary	Area under the concentration time curve (AUC) of TCN-202		60 days post infusion	No
Secondary	Time to maximum serum concentration (Tmax) of TCN-202		1 day post infusion	No