ACTRN12623000491662撤回1 期
A Phase 1, Single Centre, Open Label, Single Dose, Pharmacokinetic Study of Erwinaze in Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •1. The participant must be in good general health, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, safety laboratory tests and cardiac monitoring at screening and before administration of Erwinaze.
- •2. The participant must weigh more or equal to 50.0 kg and less or equal to 120.0 kg and have a body surface area less or equal to 2.0 m2 at screening and on Day -1.
- •3. The participant must have clinical laboratory values within the limit of normal as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the PI or if specified by protocol restrictions.
- •4. The participant must have normal vital signs after more or equal to 5 minutes resting supine:
- •a.More than 90.0 mmHg and less than 140.0 mmHg systolic blood pressure
- •b.More than 50.0 mmHg and less than 95.0 mmHg diastolic blood pressure
- •c.more than 45.0 bpm and less than 100.0 bpm heart rate
- •d.Body temperature more or equal to 35.5 and less than 37.5°C.
- •5.The participant must have a standard 12-lead electrocardiogram (ECG) parameters after more or equal to 5 minutes resting in supine position with PR more or equal to 120.0 ms and less or equal to 220.0 ms, QRS less than 120.0 ms, QTcF less or equal to 450.0 ms for males and less or equal to 470.0 ms for females, and otherwise normal ECG, unless deemed not clinically significant by the PI. Eligibility should be assessed based on average of triplicate assessments.
- •6. The participant must have a negative urine drug screen and alcohol breath test at screening and at time of admission to the CRU (on Day -1). A positive drug or alcohol screen test result may be verified by re-testing (up to 1 false positive result permitted) and may be followed up at the discretion of the PI.
- •7. The participant must have the ability and willingness to attend the necessary visits to the CRU.
- •8. The participant must sign a written informed consent prior to undergoing any of the study-specific procedures, including screening procedures.
- •9. Females must not be pregnant nor lactating, and either surgically sterile since at least 90 days prior to screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or, if women of childbearing potential (WOCBP) engaged in a sexual relationship with a fertile male partner, use highly effective double barrier contraceptive method as assessed by the PI (condom AND a vaginal ring or a non-hormonal intrauterine device [IUD]) from screening until study completion, for at least 90 days after the administration of study drug, or be post-menopausal for more or equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) per testing laboratory standards at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle and are not planning to conceive will be eligible for participation and are not required to use contraception.
- •10. WOCBP must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
- •11. Males must be surgically sterile (participants provide confirmation of the lack of viable sperm prior to screening), abstinent, or if engaged in a sexual relationship with a WOCBP, the participant and his partner must use an acceptable, highly
排除标准
- •1. Participant with medical history of or a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), hepatitis B core antigen (HbcAg) or hepatitis C virus (HCV) antibodies at screening.
- •2. The participant has previously been exposed to treatment with any form of L-asparaginase.
- •3. The participant has a current and/or past history of pancreatitis or hepatitis.
- •4. The participant has a current and/or past history of haemorrhagic or severe thrombotic events.
- •5. The participant has hyperammonemia at screening.
- •6. The participant is immunocompromised as a result of conditions and/or treatments.
- •7. The participant has an absolute neutrophil count less than 1500/microliter at screening or on Day -1.
- •8. The participant is unsuitable for the intramuscular (IM) injection of Erwinaze and the evaluation of its safety and tolerability (eg, the presence of tattoos or scarring) at either the right or the left ventrogluteal site, as defined by the PI (or qualified designee).
- •9. The participant has any underlying physical or psychological medical condition that, in the opinion of the PI, would make it unlikely for them to complete the study.
- •10. The participant has evidence and/or history of blood clotting abnormalities and/or coagulopathies.
- •11. The participant has evidence or history of any current chronic medical condition (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes).
- •12. The participant uses or is planning to use any analgesic (with the exception of paracetamol/acetaminophen up to 3000 mg per day), antibiotic, antifungals, acetylsalicylic acid (aspirin), systemic steroids, and/or any nonsteroidal anti-inflammatory drugs (NSAIDs) within 28 days prior to the initial study drug administration and/or any other prescription or over the counter (OTC) medicines (with the exception of oral contraceptives) within 7 days prior to the initial study drug administration, unless in the opinion of the PI, local medical monitor (MM) and sponsor representative (must be a physician) the medication will not interfere with the study procedures or compromise participant safety.
- •13. The participant uses or is planning to use hormone replacement therapy (HRT) medications within 30 days following Erwinaze administration, and/or has used HRT within 30 days or 5 half-lives prior to Erwinaze administration, whichever is greater.
- •14. The participant has aspartate aminotransferase (AST) and/or alanine transaminase (ALT) levels that are more than the upper limit of normal (ULN) at screening or on Day -1.
- •15. The participant has an estimated glomerular filtration rate (GFR, calculated with the CKI-EPI) less or equal to 90.0 mL/min at screening or on Day -1.
- •16 The participant has amylase levels and/or lipase levels that are above the ULN at screening or on Day -1.
- •17. The participant has any of the standard coagulation blood parameters at screening and on Day -1 that are out of normal range, and/or the participant has protein C activity, protein S activity, and/or anti-thrombin III levels that are out of normal range at screening.
- •18. The participant has fasting glucose levels outside of the normal range, per testing laboratory standards at screening or on Day -1.
- •19. The participant has a total bilirubin above the ULN at screening or on Day -1. Participants with Gilbert’s syndrome are excluded from this study.
- •20. The participant has a history of or current alcoholism or drug abuse within the 1
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