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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
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).
Time frame: 60 days post infusion
Peak serum concentration (Cmax) of TCN-202
Time frame: 1 day post infusion
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.
Time frame: 60 days post infusion
Area under the concentration time curve (AUC) of TCN-202
Time frame: 60 days post infusion
Time to maximum serum concentration (Tmax) of TCN-202
Time frame: 1 day post infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.