Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01594437

Enrollment

Registered

2012-05-09

Start date

2012-05-31

Completion date

2013-03-31

Last updated

2014-03-21

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

Conditions

Cytomegalovirus Infections

Keywords

Cytomegalovirus, Monoclonal antibody

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.

Interventions

BIOLOGICALTCN-202

Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.

BIOLOGICALPlacebo

One or two doses administered by intravenous infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult volunteers * Normal lab tests

Exclusion criteria

* Prior treatment with monoclonal antibody

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

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