ACTRN12619000417189终止1 期
A Double-Blind, Randomised, Placebo Controlled Phase I Study to assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Ascending Doses of BioE-1115 in Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 51
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 males and females aged 18-55 years, inclusive, at the time of signing the informed consent
- •2.Body Mass Index (BMI) greater than or equal to 18 kg/m2 and lesser than or equal to 30 kg/m2 and body weight greater than or equal to 50 kg and lesser than or equal to 100 kg at screening
- •3.Subjects have not used any nicotine product from 12 weeks prior to screening
- •4.No significant medical condition, and normal physical findings, vital signs (systolic blood pressure [BP]: 90- 140 mm Hg, diastolic BP: 40-90 mm Hg, pulse:40-100
- •beats per minute, respiratory rate: 10-22 breaths per minute, body temperature: 35.5-37.5 degree Celsius) and laboratory values at the time of screening, as judged by
- •the Investigator
- •5.Normal 12-lead electrocardiogram (ECG) or 1 with abnormalities that are considered clinically insignificant by the Investigator
- •6.Normal renal function (estimated glomerular filtration rate calculated using the Cockcroft-Gault equation greater than or equal to 90 mL/min)
- •7.Haemoglobin (Hb)A1C less than 5.7% and no history of fasting hyperglycaemia (glucose greater than or equal to 100 mg/dL and/or HbA1C greater than or equal to 5.7%), sustained hypertension ( greater than 95th percentile) or abnormal lipids (LDL cholesterol lesser than 130 mg/dL, TAG lesser than 130 mg/dL, HDL-C greater than 40 mg/dL).
- •8.Weight stable for at least 3 months prior to screening ( lesser than 5% change)
- •9.Subjects must be willing to not undertake any strenuous exercise within 7 days of the dosing periods, during inpatient period, and 48 hours before each follow-up visits
- •10.Female subjects must be either post-menopausal or, if pre-menopausal, must have a negative pregnancy test and agree to use 2 forms of contraception (as below) from
- •screening until 30 days after the last dose of IMP.
- •Male subjects must be surgically sterile, or if sexually active and having a pre-menopausal female partner must agree to use 2 forms of contraception (as below) for 3 months after the last dose of the IMP. They must also refrain from donating sperm from the date of dosing until 3 months after dosing of the IMP.
- •Adequate contraception allowed in this trial is defined as follows:
- •a. A condom for the male partner;
- •b. A highly effective method of birth control for the female partner, including one of the following:
- •i. Hormonal contraceptives (oral, injected or implanted) associated with suppression of
- •ii. Intrauterine devices or the implantation of intrauterine system
- •iii. Sterilization surgery such as tubal ligation in females and vasectomy in males at least 6
- •months prior to screening.
- •In addition, sexual abstinence for the entire duration of risk is acceptable if this is consistent with the usual and preferred lifestyle of the participant.
- •11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if
- •they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •a. Women lesser than 50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
- •b. Women greater t
排除标准
- •1.Any clinically significant medical, psychiatric or endocrine disorder including pharmacologically treated thyroid conditions or other disorder which, in the opinion of the Investigator, might adversely affect the safety of the subject and/or the ability of the subject to comply with study procedures
- •2.Major surgery anticipated during the study participation
- •3.Intolerance to fructose
- •4.Positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and/or human immunodeficiency virus (HIV)
- •5.Prolonged QTcF (greater than 450 ms), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the Investigator
- •6. Regular use of any prescribed or non-prescribed medications, including herbal remedies, which, in the opinion of the Investigator, might adversely affect the safety of the subject or the interpretability of study results
- •7. Regular use of agents that affect lipid metabolism, including but not limited to 5-hydroxy-3-methylglutarylcoenzyme A [HMG-CoA] reductase inhibitors (statins), orlistat, fibrates, silymarin, N acetylcysteine
- •8. Blood or plasma donation (or corresponding blood loss) within 1 month prior to screening
- •9. Inability to undergo venepuncture and/or tolerate venous access
- •10. Inability to swallow the required number of IMP tablets at the applicable dose level
- •11. History of or present alcohol abuse, or excessive intake of alcohol, as judged by the Investigator
- •12. Positive screen for drugs of abuse, nicotine use, or alcohol at screening or on admission to the clinic prior to administration of the IMP. In the event of a positive screen for drugs of abuse, the investigator may repeat the test at their discretion (i.e. if false positive result
- •13. History of severe allergy/hypersensitivity to drugs with a similar chemical structure or class to BioE-1115.
- •14. Administration of another investigational medicinal product (IMP, defined as a compound that has not been approved for marketing) or has participated in any other
- •clinical study that included IMP treatment within 3 months prior to administration of IMP in this study.
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