Clinical Trial: Viral Inhibition in Children for Treatment of RSV

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in

Brief Summary: VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.

Detailed Summary:

Globally, Respiratory Syncytial Virus (RSV) is recognized as the leading cause of respiratory tract infections in infants and young children and a major cause of hospitalization due to severe respiratory infection. Despite four decades of effort, there are still no effective methods to control RSV infection. Treatment of RSV has been limited to supportive measures. There is an urgent need for safe and effective drugs to treat and prevent RSV disease.

AK0529 is an investigational antiviral agent that targets the RSV fusion protein on the surface of the viral envelope and exerts antiviral activity against RSV by inhibiting viral entry into host cells and preventing fusion protein induced cell-cell fusion. AK0529 was generally well tolerated in healthy volunteers.

This study is designed as a randomized, double-blind, placebo-controlled, multicenter, phase 2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection. It will consist of two parts, Part 1 and Part 2. Each part will consist of three phases, a pre-treatment phase, a treatment phase and post-treatment follow-up phase.


Sponsor: Ark Biosciences Inc.

Current Primary Outcome:

  • Incidence of Adverse Events during the study [ Time Frame: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2) ]
  • Subject withdrawals due to Adverse Events [ Time Frame: Day -4 to single dose Day 7 (Part 1) and Day -3 to multiple dose Day 14 (Part 2) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Area under the plasma concentration-time curve from time 0 to infinity (AUC) [ Time Frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 ) ]
    For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
  • Maximum plasma concentration of AK0529 (Cmax) [ Time Frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 ) ]
    For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
  • Plasma concentration of AK0529 at 12 hours postdose (C12) [ Time Frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 ) ]
    For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
  • Apparent total body clearance (CL/F) [ Time Frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 ) ]
    For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
  • Apparent central compartment volume of distribution (Vc/F) [ Time Frame: Pharmacokinetic samples will be taken predose, 2, 4, 6, 12, 18, 24 hours postdose on Day 1, 48 hours postdose (Part 1 and Part 2) and Day 5 (Part 2 ) ]
    For patients without intravenous cannulation, samples will be collected at pre-dose, 2, 6 and 12 hours post-dose on Day 1.
  • Area under curve change of viral load [ Time Frame: From baseline to Day 5 ]
    The antiviral effects in infants hospitalized with RSV are to be determined by measuring the RSV viral load area under the curve in nasal, pharyngeal and tracheal washes / aspirates from baseline to last administration of study medication (Day 5).
  • Incidence of F-protein genotypes [ Time Frame: Specimen will be collected predose and 24 hours postdose on Day 1 (Part 1) and on Day 1-5 (Part 2). ]
    The incidence of F-protein genotypes associated with reduced sensitivity to IMP will be evaluated.


Original Secondary Outcome: Same as current

Information By: Ark Biosciences Inc.

Dates:
Date Received: January 4, 2016
Date Started: May 27, 2016
Date Completion: December 2017
Last Updated: March 31, 2017
Last Verified: March 2017