ACTRN12618002060224尚未招募1 期
A Phase 1, Randomised, Double-Blind, placebo controlled, single and multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of KZR-616 in healthy female subjects.
Clinical Netwprk Services0 个研究点目标入组 72 人开始时间: 2018年12月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •1. Female, normal healthy volunteer (NHV), age at screening 18 to 55 years, inclusive.
- •2. In good general health, with no significant medical history and with no clinically significant
- •abnormalities on physical examination at Screening or before administration of the initial
- •dose of study drug.
- •3. Body mass index (BMI) between 18 and 32 kg/m2 inclusive.
- •4. Suitable injection sites on abdomen without confounding scars or lesions (for Part 1 subjects)
- •or accessible venous access (for Part 2 subjects).
- •5. Agrees to abstain from alcohol intake 48 hours before administration of study agent, during
- •the inpatient period of the study and during the 24 hours prior to a study visit.
- •6. Have the ability and willingness to attend the necessary visits to the study centre.
- •7. Have provided written informed consent prior to entry into the study.
- •8. If of childbearing potential, subject has a negative serum pregnancy test at Screening and a
- •negative urine pregnancy test at Day -1 and agrees to employ adequate birth control measures
- •for the duration of the study from Screening and for 90 days following the last dose of
- •KZR-616 Lyophile.
- •a. For the purposes of this trial, women of childbearing potential (WOCBP) are defined as
- •all female subjects after puberty unless they are postmenopausal (defined by amenorrhea
- •for at least 1 year with confirmatory follicle stimulating hormone [FSH] level in the
- •postmenopausal range if subject is not on supplementary hormonal therapy; or if onhormonal replacement therapy, age over 55 and 2 years of amenorrhea) or are surgically
- •sterile (i.e. tubal ligation, hysterectomy, bilateral salpingoophorectomy) with procedure
- •performed at least 12 months prior to Screening with no evidence of pregnancy since the
- •b. Adequate birth control is defined as the use of double-barrier contraception which is
- •defined as use of a condom by the male partner and one other form of the following:
- •- i. Hormonal contraceptives: oral, implant, ring, patch, or depot/injectable method
- •which has been used for at least 4 weeks before Screening in a stable manner
- •- ii. Intrauterine device (IUD)
- •- iii. Male partner with vasectomy with documented aspermia post procedure or
- •documented congenital sterility
- •c. Rhythm, withdrawal and periodic abstinence (e.g., calendar, ovulation) methods will not
- •be considered adequate birth control for this study. Subject abstinence for the duration of
- •the study and 90 days after the last dose of KZR-616 Lyophile is acceptable. Subjects
- •with same sex partners are not required to be using contraception.
排除标准
- •Subjects must NOT meet any of the following exclusion criteria to be enrolled:
- •1. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg),
- •hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV) at Screening.
- •2. Positive QuantiFERON-TB (QFT) assay (or indeterminate result from repeat assessment) at
- •3. Active infection (diagnosed or suspected) or a history of recurrent infections (defined as 3 or
- •more infections requiring antimicrobial intervention in the last 12 months prior to Day 1).
- •4. Serious local infection or systemic infection within 3 months of Day 1 requiring injectable
- •antimicrobial treatment.
- •5. Any clinically significant acute illness within 30 days prior to Day 1.
- •6. Any underlying physical or psychological medical condition that, in the opinion of the PI,
- •would make it unlikely that the subject will complete the study.
- •7. Surgery within the past 3 months prior to the first study drug administration determined by
- •the PI to be clinically relevant.
- •8. Evidence of any ongoing chronic medical condition (e.g., hypertension, asthma or diabetes).
- •9. Use of any prescription or over-the counter (OTC) medication (with the exception of
- •multivitamin, paracetamol and hormonal contraceptives) within 7 days of randomization
- •unless PI and Sponsor agree that the specific use of a prior medication is unlikely to impact
- •the state objectives of this trial.
- •10. Receipt of any live vaccine within 1 month of randomization.
- •11. Any clinically significant laboratory abnormality.
- •12. Absolute neutrophil count <1500/µL or haemoglobin <11 g/dL.
- •13. Any other clinical laboratory values >1.2 x upper limit of normal (ULN) as specified by the
- •testing laboratory, unless deemed not clinically significant (NCS) by the PI.
- •14. History or presence of alcoholism or drug abuse within the 2 years prior to the first study
- •drug administration.
- •15. Positive urine drug screen or alcohol breath test at Screening or Day -1.
- •16. Donated or received blood products or experienced significant blood loss within 60 days prior
- •to the first study drug administration.
- •17. Donated or received plasma within 7 days prior to the first study drug administration.
- •18. Received investigational product (IP) in another trial within 30 days prior to the first study
- •drug administration.
- •19. Previously received KZR-616.
- •20. Pregnant or lactating.
- •21. Failure to satisfy the PI of fitness to participate in the study for any other reason.
- •22. Known or suspected hypersensitivity to a, a-trehalose dihydrate (trehalose).
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