ACTRN12619000021178已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising 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 63 人开始时间: 2019年1月9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
- 63
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. Male subjects must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, must agree to use contraception as described in the protocol.
- •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. 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.
- •5. Screening serum uric acid level greater than or equal to 4.5 mg/dL (268 µmol/L).
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. Subjects who have undergone major surgery within 3 months of Day 1.
- •7. Use of tobacco products within 30 days prior to dosing.
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