NCT05921006招募中1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-effect of Single and Multiple Oral Doses of RJ4287 in Healthy Volunteers
Nanjing Ruijie Pharma Co., Ltd.1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年6月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
A Randomized Study of RJ4287 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-effect of Single and Multiple Doses in Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female between 18 and 55 years old，inclusive
- •Body weight >50 kg for Male and >45 kg for Female with a body mass index BMI between 19-28 kg/m2（inclusive）
- •Female subjects of childbearing potential who have had no unprotected sex within 14 days prior to screening and who have had a negative pregnancy test during the screening period; subjects (including partners) who have no plans for pregnancy, sperm donation or egg donation and are willing to use effective contraception from the time of informed consent until 6 months after administration of the test product;
- •The subject must be willing and able to provide written informed consent
排除标准
- •History of thyroid disorder or abnormal thyroid function tests at screening
- •Abnormal abdominal ultrasound findings with clinical significance
- •Subjects with any of the following laboratory tests at screening or baseline were not eligible for enrollment in this study: 1) Glutamic transaminase (AST), glutamic aminotransferase (ALT) or direct bilirubin above the upper limit of the reference range at screening; 2) Positive screening for HIV antibodies, hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies ECG QTc > 450 ms, QRS > 110 ms, intermittent bundle branch block, frequent premature atrial or ventricular contractions at the time of screening, or any person who is considered clinically significant by the investigator; 4) A routine blood test with a white blood cell count, neutrophil count and lymphocyte count outside the normal reference range at screening and judged clinically significant by the investigator; 5) A kidney disease diet adjustment ( MDRD) formula calculated with an estimated glomerular filtration rate (eGFR) < 90 mL
- •Sensitivity to thyroid medication or history of sensitivity to a similar study drug(eg.MGL-3196)
- •History of sensitivity to a similar study drug
- •Major surgical procedure, previous gastrointestinal surgery, vagotomy, bowel resection or any surgical procedure that may interfere with peristalsis, pH or absorption in the gastrointestinal tract within 6 months prior to screening
- •Subjects who, in the judgement of the investigator, have a condition that affects the absorption, distribution, metabolism and excretion of the drug (e.g. gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc.) or who are unable to comply with a uniform diet during the trial
- •Taken any prescription medication, over-the-counter medication, any vitamin product or herbal remedy within 1 month prior to screening
- •Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results interpretation
- •History of regular use nicotine or alcohol，unable to abstain from smoking and alcohol during the trial
- •Previous blood donation or blood loss of more than 400 mL within 3 months prior to taking the study drug
- •Had consumed a special diet (including popcorn, dragon fruit, mango, grapefruit, orange, etc.) or alcohol within 2 weeks before taking the study drug, or had strenuous exercise
- •Taken an experimental drug or other experimental treatment within 3 months prior to screening, or being involved in any other interventional clinical trial
- •Nursing female subjects
- •Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for inclusion in the study
研究组 & 干预措施
RJ4287 Tablets
Experimental
single-dose or Multiple-doses, ascending dosing groups (cohorts) will be evaluated
干预措施: RJ4287 (Drug)
Placebo
Placebo Comparator
Single or multiple doses of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 1 month
Safety measurements will include vital signs, hematology, blood chemistry, blood pressure and other readouts.
次要结局
- Pharmacokinetics parameters of blood(2 weeks)
- Change in lipid / lipoprotein levels from baseline through Day 14 in Multiple Dose(2 weeks)
- Pharmacokinetics parameters of urine(2 weeks)
- Pharmacokinetics parameters of faeces(2 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese SubjectsHealthy, Overweight and/or Obese SubjectsNCT01764425Piramal Enterprises Limited32
已完成
1 期
Single Dose Study of SHR4640 in Healthy SubjectsHyperuricemia GoutNCT02815839Jiangsu HengRui Medicine Co., Ltd.50
Unknown
1 期
Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187OverweightDiabetes Mellitus Type 2 in ObeseNCT01874366Piramal Enterprises Limited96
已完成
1 期
A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male VolunteersHealthyNCT02470286Samjin Pharmaceutical Co., Ltd.40
招募中
1 期
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418Parkinson Disease PsychosisAmyotrophic Lateral Sclerosis (ALS)NCT059957821ST Biotherapeutics, Inc.64