A Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single dose of brincidofovir administered intravenously in healthy adult subjects
Chimerix, Inc
40 participants
Nov 29, 2016
Interventional
Conditions
Summary
This is the first clinical study administering a new intravenous formulation of BCV. BCV has been studied in hundreds of patients as an oral formulation for the treatment of adenovirus and for the treatment and prevention of cytomegalovirus following stem cell transplantation. This first IV BCV study will investigate the safety and tolerability following single escalating doses to healthy subjects to observe how the new formulation compares to the oral formulations.
Eligibility
Inclusion Criteria7
- non-child bearing potential
- willing and able to provide written informed consent
- non-tobacco/non-nicotine user in the past 6 months
- body weight no greater than 50kg
- BMI from 18-32 kg/m
- no significant medical history
- males cannot donate sperm during participation
Exclusion Criteria4
- child bearing potential
- investigational drug or clinical study in the past 30 days
- had any infection within the past 2 weeks
- history of history chronic liver disease
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Interventions
4 cohorts Intravenous (IV) brincidofovir (BCV) 10mg or IV Placebo, single dose-6 active and 2 placebo IV BCV 25mg or IV Placebo, single dose-6 active and 2 placebo IV BCV 50mg or IV Placebo, single dose-9 active and 3 placebo IV BCV 100mg or IV Placebo, single dose-9 active and 3 placebo Dose escalation will be based on safety, tolerability, and pharmacokinetics of each cohort. A safety and PK review by the Chimerix Study Team and the Principal Investigator (PI) will occur prior to escalation to the next dose level.
Locations(1)
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ACTRN12616001657415