None listed
Conditions
Brief 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.
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
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.
Sponsors
Chimerix, Inc
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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
Outcome results
None listed