NCT04706923

A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection

A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV

Detailed description

This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW (Cohorts 1 to 4) in adult and pediatric subjects with AdV viremia, and IV BCV in subjects with CMV.

Conditions

• Adenovirus Infections
• Cytomegalovirus Infection

Interventions

Type	Name	Description
DRUG	BCV	Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.

Timeline

• Start date: 2021-08-16
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2021-01-13
• Last updated: 2024-06-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study