ACTRN12620000829910已完成1 期
A Phase 1, Open-label Study to Determine the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Doses of Pentosan Polysulfate Sodium (PPS) in Healthy Adult Participants
Paradigm Biopharmaceuticals Pty Ltd0 个研究点目标入组 23 人开始时间: 2020年8月19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
- 23
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Healthy male or female volunteers, aged grater than or equal to 18 years and less than or equal to 75 years (at the time of informed consent);
- •Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug;
- •Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI) greater than or equal to 18.0 and less than or equal to 35.0 kg/m2 at Screening
- •Participants who smoke no more than 10 cigarettes or equivalent per week can be included in the study but must agree to abstain from smoking and all nicotine containing products from 48 hours before each visit
- •Must agree to abstain from alcohol intake from 48 hours before each visit
- •Subjects must be able to provide written informed consent
排除标准
- •History of severe allergic or anaphylactic reactions
- •Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period
- •Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol
- •Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug
- •Blood donation or significant blood loss within 60 days prior to the first study drug administration
- •History of malignancy except for non-melanoma skin cancer excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening
- •History of heparin induced thrombocytopenia
- •Participants undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, tissue plasminogen activator (t-PA), streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs [NSAID]). Participants may be enrolled if they satisfy the following criteria with regard to NSAID:
- •Participants taking NSAIDs continuously (i.e., daily) agree to a washout period of at least 7 days prior to admission on Day -1;
- •Participants taking NSAIDs intermittently (i.e., less than daily) agree to a washout period of at least 24 hours prior to admission on Day -1;
- •NSAIDs are not permitted from Day -1 through to the EOS visit
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