ACTRN12616000700437已完成1 期
Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety of Intravenous APL-2 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
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
- All
入选标准
- •1.Healthy male or female,
- •2.Continuous non-smoker for at least 3 months prior to dosing.
- •3.Weigh more than or equal to 55 kg and less than or equal to 90 kg and have a Body Mass Index (BMI) of greater than or equal to 18.5 and less than or equal to 32.0 kg/m2.
- •4.Medically healthy with no clinically significant screening results as deemed by the principal investigator (PI).
- •5.Able to provide documentary evidence of vaccination with Neisseria menigitides types A, C, W, Y and B, Streptococcus pneumoniae (PCV13 or PPSV23) and Haemophilus influenza (Hib) within 2 years of dosing, or willing to receive vaccinations against Neisseria menigitides, PCV13 and Hib vaccines at least two weeks prior to dosing.
- •6.Women of child bearing potential (WOCBP) must have a negative pregnancy test at screening and during the study and must agree to use protocol defined methods of contraception for the duration of the study.
- •7.Women of non-childbearing potential (WONCBP) must have undergone one of the protocol defined sterilization procedures at least 6 months prior to dosing or be postmenopausal for at least 1 year prior to dosing and have FSH serum levels consistent with postmenopausal status upon Screening.
- •8.Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for 3 months after the final dose of APL-2.
- •10.Willing and able to give informed consent.
排除标准
- •1.Mental or legal incapacitation or significant emotional problems at screening or expected during the study in the opinion of the PI.
- •2.History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator (PI).
- •3.History of any illness that, in the opinion of the PI, might confound the study results or poses an additional risk to the subject by their participation in the study.
- •4.History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
- •5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product.
- •6. History of chronic infections or active infection at check-in (as determined by the PI)
- •7.Pregnant or lactating women.
- •8.Positive results for the urine drug or alcohol breath test at screening or check-in.
- •9.Positive urine cotinine at screening or check in.
- •10.Positive results at screening for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •11.Clinically relevant clinical laboratory results at screening or check in, as deemed by the PI.
- •12.Seated systolic blood pressure less than 90/40 mmHg or greater than 140/90 at screening or greater than 155/90 mmHg at any other assessment prior to dosing.
- •13.Heart rate lower than 40 bpm or higher than 99 bpm at screening or at any other assessment prior to dosing.
- •14.QTcF interval greater than 450 msec for males or greater than 470 msec for females, or history of prolonged QT syndrome at screening or prior to dosing.
- •15.Estimated creatinine clearance (CrCl) less than 90 mL/min (Cockcroft Gault formula)or serum creatinine greater than 1.5 mg/mL (133 µmol/L) at screening.
- •16. Unable to refrain from or anticipates the use of:
- •-Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements from 14 days prior to dosing and throughout the study, with the exception of paracetamol.
- •-Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John’s Wort, for 28 days prior to dosing and throughout the study.
- •17.Blood donation or significant blood loss within 56 days prior to dosing.
- •18.Plasma donation within 7 days prior to dosing.
- •19.Participation in another clinical trial within 28 days prior to dosing.
- •20.Clinically relevant surgery within 90 days prior to dosing..
- •21.Any condition or circumstance, in the opinion of the PI, which may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject’s safety.
- •22.Subjects who have participated in the any study with APL-2.
研究者
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