A Phase I study assessing the pharmacodynamic and pharmacokinetic equivalence of HSP-130 with US-approved Neulasta (Registered Trademark) and EU-approved Neulasta (Registered Trademark) administered as a single subcutaneous dose to healthy volunteers.

Hospira, Inc.0 个研究点目标入组 150 人开始时间: 2015年10月7日最近更新: 2020年1月13日

适应症

试验速览

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•BMI between 19 and 30 kg/m2, inclusive, and BW of not < 50 kg or > 100 kg
•- Non-smoker (defined as a subject who has not smoked and has not used nicotine containing products for at least 3 months prior to study drug administration and has a negative urine screen for cotinine) at Screening
•- Female subjects of childbearing potential and male subjects and their partners of childbearing potential, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Subjects and their partners must agree to use an effective method of contraception, to avoid impregnation of females throughout the course of the study.

•- Hematologic laboratory abnormalities including leukocytosis, leukopenia, neutropenia or thrombocytopenia.
•- History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disease, chronic neutropenia, thrombocytopenia, or vasculitis.
•- Clinically significant as judged by the investigator, vital sign or 12-lead ECG abnormality.
•- Any clinically significant, as determined by the investigator, abnormal laboratory evaluations, including HIVAb, HBsAg, HCV Ab, and liver function including ALT and AST > 1.5 the ULN taken at screening.
•- Use of any prescription medicine (exception contraceptives) within 7 days or at least 5 half-lives, whichever is longer. Use of oral or parenteral anticoagulant or antiplatelet agents and corticosteroids should be specifically queried.

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