CTRI/2021/10/037600招募中1 期
A Two-Part, Randomized, Double-Blind, Single-Dose, Three-Period, Crossover StudyEvaluating the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, andImmunogenicity between BSC-0826 and US-licensed Neulasta and EU-approvedNeulasta Part 1, and Randomized, Double-Blind, Two-Dose, Parallel Arm StudyEvaluating the Safety and Immunogenicity in Part 2 of BSC-0826 to EU-Neulasta�®following Subcutaneous Administration to Healthy Subjects
Veeda Clinical Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Understands the study procedures in the informed consent form (ICF), and be willing and
- •able to comply with the protocol.
- •2. Healthy, adult, male or female, 18-55 years of age, inclusive, at the time of ICF signing.
- •3. Continuous non-smoker who has not used nicotine-containing products for at least
- •3 months prior to the first dosing and throughout the study, based on subject self-reporting.
- •4. Body mass index (BMI) ââ?°Â¥ 18 and ââ?°Â¤ 30.0 kg/m2 and with body weight between 45 kg and
- •100 kg, at screening.
- •5. Medically healthy with no clinically significant medical history, physical examination,
- •laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- •6. A female of childbearing potential is either sexually inactive (abstinent as a lifestyle) for
- •28 days prior to the first dosing and throughout the study or using one of the following
- •acceptable birth control methods:
- •hormonal oral contraceptives, vaginal ring, transdermal patch, hormone or
- •non-hormone releasing intrauterine device for at least 3 months prior to the first dosing
- •and throughout the study.
- •Ã¢â?¬Â¢ depot/implantable hormone (e.g., Depo-proveraÃ?®, Implanon) for at least 3 months prior
- •to the first dosing and throughout the study.
- •Ã¢â?¬Â¢ surgical sterilization of the partner (vasectomy for 4 months minimum prior to the first
- •Ã¢â?¬Â¢ physical barrier method (e.g., condom, diaphragm) with spermicide for at least 14 days
- •prior to the first dosing and throughout the study.
- •A female subject who claims to be sexually inactive, but becomes sexually active during
- •the course of the study must agree to use a physical barrier method (e.g., condom,
- •diaphragm) with spermicide from the time of the start of sexual activity and throughout the
- •In addition, female subjects of childbearing potential will be advised to remain sexually
- •inactive or to keep the same birth control method for at least 28 days after the last dose.
- •7. A female of non-childbearing potential has undergone one of the following sterilization
- •procedures at least 6 months prior to the first dosing:
- •Ã¢â?¬Â¢ hysteroscopic sterilization;
- •Ã¢â?¬Â¢ bilateral tubal ligation or bilateral salpingectomy;
- •Ã¢â?¬Â¢ hysterectomy;
- •Ã¢â?¬Â¢ bilateral oophorectomy;
- •or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and
- •follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- •8. A non-vasectomized, male subject must agree to use a condom with spermicide or abstain
- •from sexual intercourse during the study until 90 days after the last dosing. (No restrictions
- •are required for a vasectomized male provided his vasectomy has been performed 4 months
- •or more prior to the first dosing. A male who has been vasectomized less than 4 months
- •prior to study first dosing must follow the same restrictions as a non-vasectomized male).
- •9. If male, must agree not to donate sperm from the first dosing until 90 days after the last
- •10. Agrees to abstain from alcohol consumption throughout duration of the study and has a
- •negative alcohol breath test at screening and first check-in.
排除标准
- •1. Is mentally or legally incapacitated or has significant emotional problems at the time of the
- •screening visit or expected during the conduct of the study.
- •2. History or presence of clinically significant medical or psychiatric condition or disease in
- •the opinion of the PI or designee.
- •3. History of any illness that, in the opinion of the PI or designee, might confound the results
- •of the study or poses an additional risk to the subject by their participation in the study.
- •4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- •5. Any active systemic or immunologic disease or condition, including but not limited to the
- •following general categories: cardiovascular/pulmonary, hepatorenal, or systemic
- •infection, or lactation.
- •6. Hematologic laboratory abnormalities including leukocytosis (defined as total leukocytes
- •> 11,000/Ã?¼L), leukopenia (defined as total leukocytes < 4000/Ã?¼L), or neutropenia (defined
- •as ANC < 1500/Ã?¼L) or thrombocytopenia (defined as platelet count of < 150/Ã?¼L).
- •7. History of biological growth factor exposure, including but not limited to filgrastim,
- •pegfilgrastim, and other G-CSFs in the context of treatment, prophylaxis, peripheral blood
- •stem cell mobilization, or previous investigational study setting.
- •8. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to
- •E. coli-derived proteins, filgrastim, pegfilgrastim, other G-CSFs, or any component of the
- •product: Subjects with the rare heredity problem of fructose intolerance are excluded due
- •to the excipient sorbitol.
- •9. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia,
- •sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis.
- •10. History or presence of:
- •Ã¢â?¬Â¢ febrile or infectious illness within 1 week of first dose.
- •Ã¢â?¬Â¢ clinically significant skin disorders, including psoriasis.
- •11. History of pulmonary infiltrate or pneumonia within 6 months of first dose. Chest X-ray
- •will be performed at screening.
- •12. History of cancer with the exception of basal/squamous skin cell cancer.
- •13. Acute infection within one month of first dose, deemed clinically significant in the opinion
- •of the Investigator or designee.
- •14. No vaccination (including influenza) within 30 days of first dose of study drug. COVID-
- •19 vaccination is allowed during the study however, the subject will not receive next dose
- •until 4 weeks past vaccination.
- •15. Female subjects with a positive pregnancy test at screening or first check-in or lactating.
- •16. Positive urine alcohol or urine drug of abuse results (including amphetamines, barbiturates,
- •benzodiazepines, cocaine, morphine, and marijuana) at screening or first check-in.
- •17. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface
- •antigen (HBsAg) or hepatitis C virus (HCV).
- •18. Positive COVID-19 result at screening by RT-PCR testing.
- •19. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
- •20. Seated heart rate is lower than 50 bpm or higher than 85 bpm at screening.
- •21. QTcF interval is >460 msec (males)
研究者
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