RecruitingPhase 1ACTRN12616001657415

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


Sponsor

Chimerix, Inc

Enrollment

40 participants

Start Date

Nov 29, 2016

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new intravenous (IV) formulation of brincidofovir — a drug previously studied as an oral treatment for viral infections such as adenovirus and cytomegalovirus — to see whether it is safe and tolerable when given by injection. Healthy adult volunteers will receive a single dose and be monitored for any side effects. You may be eligible if: - You are between 18 and 55 years old - You are generally healthy with no significant medical history - You have not smoked or used nicotine products in the past 6 months - Your weight is no greater than 50 kg and your BMI is between 18 and 32 - You are not of child-bearing potential (or you meet specific contraception requirements) You may NOT be eligible if: - You are a woman who could become pregnant - You have participated in another clinical study in the past 30 days - You have had any infection in the past 2 weeks - You have a history of chronic liver disease Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

New Zealand

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ACTRN12616001657415


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