Clinical Trial: A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Study Assessing The Pharmacodynamic And Pharmacokinetic Equivalence Of HSP-130 With US-approved Neulasta (Registered) And EU-approved Neulasta (Registered) Administered As A Single Subcutane

Brief Summary: This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.

Detailed Summary: There will be 25 healthy participants in each of the six sequence groups. A total of 150 participants will be studied in one site in Australia. In addition to the 150 participants included, alternate subjects will be asked to come to the site on the day prior to when dosing is scheduled to begin. There will be 3 treatment options with 3 study dosing periods (1, 2 and 3) and at least 56 days between each treatment. The subject once asked to take part in the study will be assigned by chance (randomized) to one of the sequence groups as mentioned above (1, 2, 3, 4, 5, or 6).
Sponsor: Pfizer

Current Primary Outcome:

  • Area under the effect versus time curve for absolute neutrophil count (ANC) from the time of dose administration to 288 hours after dose administration (AUECANC) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Maximum observed value for ANC (ANC_Cmax) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time of maximum value for ANC (ANC_Tmax) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Area under the serum pegylated filgrastim versus time curve from the time of dose administration to time infinity (AUC0-∞) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Maximum observed serum pegylated filgrastim concentration (Cmax) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Area under the serum pegylated filgrastim versus time curve from the time of dose administration to the time of last measurable concentration (AUC0-t) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Time to maximum serum pegylated filgrastim concentration (Tmax) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Elimination half-life (t1/2) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Elimination rate constant (λz) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]


Original Secondary Outcome:

  • Time of maximum value for ANC (ANC_Tmax) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Area under the serum pegylated filgrastim versus time curve from the time of dose administration to time infinity (AUC0-∞) [ Time Frame: Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Maximum observed serum pegylated filgrastim concentration (Cmax) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Area under the serum pegylated filgrastim versus time curve from the time of dose administration to the time of last measurable concentration (AUC0-t) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Time to maximum serum pegylated filgrastim concentration (Tmax) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose. ]
  • Elimination half-life (t1/2) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose ]
  • Elimination rate constant (λz) [ Time Frame: Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose ]


Information By: Pfizer

Dates:
Date Received: December 10, 2015
Date Started: August 2015
Date Completion:
Last Updated: July 14, 2016
Last Verified: July 2016