ACTRN12618001077257已完成1 期
A Phase I, Two-Part, Single-Center, Open-Label, Randomized, Cross Over, Single Ascending Doses (SAD), followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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 45 Years（—）
- 性别
- All
入选标准
- •1.Healthy male or female, 18 to 45 years of age (inclusive at time of informed consent)
- •2.Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures
- •3.Normal heart, lung, kidney, and liver function based on physical examination
- •4.Systolic blood pressure of 100-145 mmHg, diastolic blood pressure of 50-90 mmHg, and a resting heart rate of 40-100 beats per minute at Screening
- •5.Body mass index within the range of 18.0 to 32.0 inclusive at Screening
- •6.Must be a non-smoker or ex-smoker with less than a 5-pack year history of smoking (including the use of electronic cigarettes) and have ceased smoking over 1 year prior to Screening; or a social smoker (defined as less than 10 cigarettes in the previous 12 months)
- •7.Females must be non-pregnant and non-lactating, and either surgically sterile or use highly effective contraceptive method from Screening until study completion, including the follow-up period, or be post menopausal for more than 12 months. Postmenopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels . Females who are abstinent from heterosexual intercourse will also be eligible.
- •Males must be surgically sterile (more than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from Screening until study completion, including the follow-up period.
- •Subjects with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
- •Women of child-bearing potential must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study
排除标准
- •1.Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period
- •2.Known hypersensitivity to active drug substance or drugs of the same class, or any excipients of the drug formulation(s)
- •3.History or clinical evidence of any disease and or medical condition which may interfere with the absorption, distribution, metabolism, or excretion of the study treatment
- •4.Has serum transaminase levels greater than three times the upper level of normal
- •5.Abnormal orthostatic vital signs (at screening) defined as a decrease of greater than or equal to 20 mmHg in systolic blood pressure and or a decrease of greater than or equal to 10 mmHG in gystolic blood pressure and or greater than 25 beats per minute increase in heart rate within 3 minutes of standing, or with symptoms of lightheadedness, dizziness, or fainting upon standing.
- •6.History of hypotension including fainting, syncope, orthostatic hypotension, and or vasovagal reactions
- •7.History of cardiopulmonary diseases (cardiovascular, pulmonary, and pleural disorders) and/or cardiopulmonary symptoms of breathlessness, cough and or wheezing
- •8.History of drug abuse
- •9.History of alcohol abuse (defined as more than 12 standard drinks per week), consumption food or drink containing grapefruit or seville orange within 72 hours before start of dosing or expected to do so through end of study/early termination
- •10.Use of any prescription drugs (other than hormonal contraception; OCP’s, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD), non-prescription drugs, herbal remedies, supplements or vitamins 2 weeks prior to dosing and during course of study without prior approval of the Investigator and Medical Monitor.
- •11.History of retinitis pigmentosa
- •12.Vision loss due to non-arteritic anterior ischemic optic neuropathy or other optic perfusion impairment
- •13.History of priapism or anatomical deformation of the penis
- •14.History of sudden sensorineural hearing loss (SSHL), need for hearing aids, and or other documented hearing loss
- •15.A corrected QT interval using Fridericia’s formula (QTcF) greater than 450 msec
- •16.Has evidence of significant obstructive lung disease on spirometry. Subjects with any of the following criteria will be excluded:
- •a. Forced expiratory volume in 1 second (FEV1 ) less than 60% (predicted) (pre bronchodilators); or
- •b. Forced expiratory volume in 1 second/forced vital capacity ratio (FEV1/FVC) less than 65% (pre-bronchodilators)
- •17.Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest) or participation in more than four investigational drug studies within 1 year prior to Screening
- •18.Presence or history of any condition that, in the view of the Investigator, may affect full participation or compliance with the protocol, or would affect safety
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