ACTRN12613000386730已完成1 期
A Phase I, double blind, randomised, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of FT011 administered orally to healthy volunteers and patients with diabetic nephropathy associated with Type 2 diabetes
Fibrotech Therapeutics Pty Ltd0 个研究点目标入组 80 人开始时间: 2013年4月10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
- 80
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 70 Years（—）
- 性别
- Male
入选标准
- •Healthy volunteers (Part A, Part B, Part C):
- •- Male aged 18 to 45 years old inclusive
- •- Good general health without clinically significant medical history
- •- Body mass index < 30
- •Patients (Part C):
- •- males aged 18 to 70 years old inclusive
- •- have Diabetes Mellitus Type 2
- •- have overt albuminuria
- •- have eGFR >/= 30 and < / = 60 mL/min
- •- currently taking either an ACEi or an ARB at a stable dose.
排除标准
- •Healthy volunteers (Part A, Part B, Part C):
- •- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose, or an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- •- Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months.
- •- Have had serious angioedema episodes within the previous 3 years or requiring angioedema medication in the previous two years.
- •- Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- •- Have any clinically significant abnormality at Screening (determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse), a psychiatric condition that precludes compliance with the protocol, or any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- •- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma
- •Patients (Part C):
- •- Have a history of untreated or uncontrolled proliferative or pre-proliferative diabetic retinopathy
- •- Have evidence of hepatic dysfunction, HbA1c > 11.0%, serum potassium > 6 mmol/L.
- •- Have untreated urinary tract infection or other medical conditions that impact urinary protein values
- •- Have unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure.
- •- Have a history of any major medical condition or any condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- •- Have any risk of bleeding
- •- Use of anticoagulant drugs including warfarin or heparin, low molecular weight heparin, danaparoid, hirudin, or others.
- •- Have other specific renal conditions known to be the cause of renal disease, and patients with other specific, clinically significant renal disease.
- •- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma.
研究者
相似试验
已完成
1 期
A Phase I, randomised, double blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and repeat doses of AMP945 administered orally to healthy adult volunteersCancer - PancreaticRespiratory - Other respiratory disorders / diseasesPancreatic cancerIdiopathic pulmonary fibrosisACTRN12620000894998Amplia Therapeutics Limited56
已完成
1 期
Anti-inflammatory treatment for dermatological disorders.Inflammatory skin diseasesPsoriasisSkin - Dermatological conditionsACTRN12613001226796Akaal Pharma Pty Ltd19
招募中
1 期
Safety and tolerability Phase I study of a new immunomodulatory drug in healthy participants after single and repeat doses.Multiple SclerosisACTRN12618001769279Akaal Pharma Pty Ltd64
招募中
1 期
TLB-001 safety and tolerability studyRespiratory - Other respiratory disorders / diseasesIdiopathic pulmonary fibrosisACTRN12624000813583Tianli Biotech Pty Ltd64
已完成
1 期
A Phase I, randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of OCX063 administered orally to healthy volunteersFibrotic ocular diseasesInflammatory ocular diseasesEye - Diseases / disorders of the eyeACTRN12619001607167OccuRx Pty Ltd64