ACTRN12619000908134已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc.0 个研究点目标入组 30 人开始时间: 2019年6月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- Male
入选标准
- •1.Healthy male adult subjects greater than or equal to 18 and lesser than or equal to 55 years of age.
- •2.Males must be surgically sterile, abstinent* or, if engaged in sexual relations with a female of child-bearing potential, the subject must agree to use 2 forms of a highly effective contraceptive methods from the time of signing the informed consent form until at least 90 days after receiving IP (AR882 or placebo).
- •* Abstinence is only acceptable as true abstinence as part of a preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar ovulation, symptom-thermal, post-ovulation methods), declaration of abstinences for the duration of the trial and withdrawal are not acceptable methods of contraception.
- •3.Males must agree to refrain from sperm donation from the time of signing the informed consent form until at least 90 days after receiving IP (AR882 or placebo).
- •4.Able to understand the study procedures, the risks involved and willing to provide written Informed Consent before the first trial related activity.
- •5.Body weight no less than 50 kg and body mass index (BMI) within the range of
- •greater than or equal to 18 and lesser than or equal to 33 kg/m2.
- •6.All laboratory parameters (chemistry, hematology, and urinalysis) should be within normal limits or considered not clinically significant by the Investigator, in consultation with the Sponsor.
- •7.Screening serum uric acid level greater than or equal to 4.5 mg/dL (268 micromol/L) and less than 9 mg/dL (535 micromol/L) and estimated Glomerular Filtration Rate (eGFR) greater than or equal to 90 mL/min/1.73 m².
- •8.Subjects must be free of any clinically significant disease that requires a physician’s care and/or would interfere with study evaluations or procedures.
- •9.Normal or clinically acceptable physical examination.
- •10.No clinically relevant abnormalities in twelve-lead electrocardiogram as per Investigator judgment.
- •11.No clinically relevant abnormalities in blood pressure (BP), heart rate (HR), body temperature and respiratory rate as per the Investigator’s judgment, see normal values for information:
- •a.90 mm Hg lesser than or equal to systolic BP lesser than or equal to 140 mmHg in supine position.
- •b.40 mm Hg lesser than or equal to diastolic BP lesser than or equal to 90 mm Hg in supine position.
- •c.40 bpm lesser than or equal to heart rate lesser than or equal to 100 bpm in supine position.
- •d.35.5 °C lesser than or equal to body temperature lesser than or equal to 37.5 °C.
- •e.10 bpm lesser than or equal to respiratory rate lesser than or equal to 22 bpm.
排除标准
- •1. Inadequate venous access or unsuitable veins for repeated venipuncture.
- •2. Any concomitant chronic or acute illness or an acute febrile illness within 1 week
- •of dose administration.
- •3. Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies (HCV),
- •and/or Hepatitis B surface antigen (HBsAg).
- •4. History or clinical manifestations of significant metabolic, hematological,
- •pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological,
- •or psychiatric disorders.
- •5. Malignancy within 5 years, except for basal or squamous cell carcinoma of the
- •skin that has been successfully treated. Healthy volunteers with a history of other
- •malignancies that have been treated with curative intent and which have no
- •recurrence within 5 years may also be eligible if approved by the Sponsor
- •Medical Monitor (or designee).
- •6. History of cardiac abnormalities including abnormal and clinically relevant ECG
- •changes such as bradycardia (sinus rate < 40 bpm), complete LBBB, RBBB,
- •incomplete LBBB, second or third degree heart block, intraventricular conduction
- •delay with QRS duration > 120 msec, symptomatic or asymptomatic arrhythmias
- •with the exception of sinus arrhythmia, evidence of ventricular pre-excitation,
- •frequent palpitations or syncopal episodes, heart failure, hypokalemia, family
- •history of Long QT Syndrome, family history of sudden death in otherwise
- •healthy individual between the ages of 1 and 30 years.
- •7. Conditions predisposing to QT prolongation including pathological Q-wave
- •(defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- •8. Any use of concomitant medications that prolong the QT/QTc interval within
- •14 days prior to Day 1.
- •9. Subjects with a QTcF interval (QT interval corrected for heart rate according to
- •Fridericia) > 450 milliseconds (ms) at Screening or on Day –1 or at pre-dose on
- •10. Subjects who have undergone major surgery within 3 months of Day 1.
- •11. Subjects who previously received AR882 or an investigational product, biological
- •agent, or device within 3 months or 5 half-lives of the investigational agent,
- •whichever is longer.
- •12. Subjects who donated blood within 12 weeks prior to Day 1 or who have given a
- •plasma donation within 4 weeks prior to the screening visit.
- •13. Any drug treatment, including prescribed or OTC medicines or herbal
- •preparations, taken in the 14 days (2 months for enzyme-inducing drugs or
- •products e.g., glucocorticoids, phenobarbital, isoniazid, St. John’s Wort)
- •preceding the dosing of IP.
- •14. Use of tobacco products within 30 days prior to dosing.
- •15. Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee,
- •tea, cola per day).
- •16. Subjects who refuse to abstain from alcohol, or caffeine containing foods or
- •beverages, or grapefruit containing foods or beverages, or Seville orange
- •containing foods or beverages, or fruit juice, or sweetened soft drinks from 48
- •hours prior to dosing and for the entire duration of the study.
- •17. History and/or presence of drug addiction or excessive use of alcohol within 6
- •months prior to Screening defined as > 14 drinks/week (1 drink = 5 ounces
- •(150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard
- •18. Subjects who have a positive alcohol test (breath or urine test) at Screening or at
- •Day -2 (Admission).
- •19. Subjects who have a positive test for drugs of abuse (cocaine,
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