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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
153
CMAX (a Division of IDT Australia Limited)
Adelaide, South Australia, Australia
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.
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.
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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.