ACTRN12618001920280已完成1 期
Safety and Tolerability of Single Ascending Doses (SAD) of a Novel Engineered Cationic Peptide PLG0206 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
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 45 Years（—）
- 性别
- All
入选标准
- •1. Male or female between 18 and 45 years of age (inclusive). Females of child bearing potential using oral contraceptives who agree to use two reliable methods of contraception (e.g., double-barrier condom plus diaphragm, condom or diaphragm along with stable dose of oral contraception) throughout the study perilod and until 3 months after receiving study drug. Women of childbearing potential will require compulsory pregnancy testing. A negative serum pregnancy test is required at screening, and a negative urine pregnancy test is required at Day -1 if Day -1 > 7 days from screening.
- •2. Healthy with no clinically significant medical problems.
- •3. BMI between 18 and 30 kg/m2 with weight between 45 and 100 kg (both inclusive) at Day -1.
- •4. No history of alcohol or drug abuse (Barbiturates, Benzodiazepines, Cocaine, Methadone, Amphetamines, Methamphetamines, Opiates, Phencyclidine, Tetrahydrocannabinol (cannabis), Tricyclic Antidepressants). Subjects should be enrolled only after passing the urine drug screen.
- •5. Non-smokers or light smokers (less than 5 cigarettes per week) by history and planned during study.
- •6. No history of significant allergies such as urticaria, angioedema or anaphylaxis.
- •7. No prior exposure to PLG0206.
- •8. Willing and able to sign written, informed consent.
排除标准
- •1. Any significant past or current cardiac, pulmonary, hepatic, renal or other medical condition which in the opinion of the investigator would make participation of the subject in this study medically unsafe or compromise the accuracy of assessment of the study.
- •2. Subjects who have safety laboratory values outside the local laboratory reference ranges considered clinically significant as per Principal Investigator’s (PI’s) discretion (can be repeated once at screening as per PI’s discretion).
- •3. Current use of any prescription medications, except oral contraceptives.
- •4. Use of non-prescription medications including vitamins, antacids, herbal and
- •dietary supplements including St John’s Wort within 7 days (or 14 days if the
- •drug is a potential enzyme inducer) or 5 half-lives whichever is longer, prior to
- •the first dose of study medication.
- •5. Subjects with past medical history of malignancy except basal cell or squamous cell carcinoma of the skin who have had curative surgical treatment and at least 6 months has elapsed since the procedure.
- •6. A value outside the specified range of 90 mm Hg – 140 mm Hg for systolic blood pressure (BP) and 50 mm Hg –90 mm Hg for diastolic BP (both inclusive) at screening (can be repeated once at screening as per PI’s discretion).
- •7. History of clinically significant acute bacterial, viral, or fungal systemic infections in the last 4 weeks prior to screening.
- •8. Clinical or laboratory evidence of an active infection at the time of screening.
- •9. Serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antihepatitis C virus (Anti-HCV) at screening.
- •10. QTcF > 450 msec
- •11. Vaccination within 3 months of screening for the study or requiring vaccination during the study or within 3 months after completion of the study.
- •12. Females who are pregnant or nursing.
- •13. Participation in any other investigational medicinal product study within 8
- •weeks or 5 half-lives of the study drug, whichever is longer, prior to screening.
- •14. Unable or unwilling to comply with the protocol requirements for study visits and procedures.
- •15. Subjects who do not have good venous access for infusion of study drug or for blood sampling.
- •16. History of hypersensitivity to diphenhydramine or paracetamol.
- •17. History of any other hypersensitivity reaction as deemed clinically significant by the Principal Investigator.
- •18. Any significant clinical finding or history that in the opinion of the investigator could affect study results or be associated with higher risk for the subject.
- •19. Blood donation during the period of study from screening visit to termination visit at Day 7.
- •20. Any condition that may prevent the patient to receive the PLG0206 or may interfere with the PK of PLG0206.
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