None listed
Conditions
Brief summary
This is the second 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 second IV BCV study will investigate the safety and tolerability following multiple ascending doses to healthy subjects to observe how the new formulation compares to placebo and the oral formulations.
Interventions
4 cohorts
Intravenous (IV) brincidofovir (BCV) 10 mg or IV placebo administered over 2 hours, twice per week (BIW)-3 active and 1 placebo. Subjects in BIW cohorts will be dosed on Day 1, Day 4, Day 8 and Day 11 (i.e., 1.5 weeks).
IV BCV 20 mg or IV placebo administered over 2 hours, once a week (QW)-6 active and 2 placebo. Subjects in QW cohorts will be dosed on Day 1, Day 8, Day 15, Day 22 (i.e., 3 weeks).
IV BCV 20 mg or IV placebo administered over 1 hour, QW-6 active and 2 placebo. Subje
4 cohorts Intravenous (IV) brincidofovir (BCV) 10 mg or IV placebo administered over 2 hours, twice per week (BIW)-3 active and 1 placebo. Subjects in BIW cohorts will be dosed on Day 1, Day 4, Day 8 and Day 11 (i.e., 1.5 weeks). IV BCV 20 mg or IV placebo administered over 2 hours, once a week (QW)-6 active and 2 placebo. Subjects in QW cohorts will be dosed on Day 1, Day 8, Day 15, Day 22 (i.e., 3 weeks). IV BCV 20 mg or IV placebo administered over 1 hour, QW-6 active and 2 placebo. Subjects in QW cohorts will be dosed on Day 1, Day 8, Day 15, Day 22 (i.e., 3 weeks) IV BCV 20 mg or IV placebo administered over 1 or 2 hours, BIW-6 active and 2 placebo. Subjects in BIW cohorts will be dosed on Day 1, Day 4, Day 8 and Day 11 (i.e., 1.5 weeks). The 1 or 2 hour infusion time will be determined by the Sponsor and Principal Investigator following safety and PK review from previous cohorts. All doses will be administered in the study clinic and will be recorded in the case report form.
Sponsors
Chimerix, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
willing and able to provide written informed consent vasectomized male or female of non-childbearing potential non-tobacco/non-nicotine user in the past 6 months body weight greater than 50kg BMI from 18-32 kg/m2 no significant medical history
Exclusion criteria
child bearing potential investigational drug or clinical study in past 30 days positive for HBV, HCV, HIV. had any infection within past 2 weeks history of chronic liver disease
Outcome results
None listed