Neutropenia Clinical Trial
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 Subcutaneous Dose To Healthy Volunteers
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). ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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