NCT04775615Unknown1 期
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Healthy Subjects-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 主要终点
- Number of Subjects with Adverse Events (AE)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy volunteers aged 18-45 years;
- •Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
- •Signed informed consent.
排除标准
- •Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
- •A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, Total bilirubin, direct bilirubin, indirect bilirubin ；
- •Subjects with a value at screening is greater than the upper limit of reference range for serum creatinine;
- •Subjects with a positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
- •Subjects with blood loss ≥400mL within 3 months before screening;
- •Subjects has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
- •Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;
- •Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.
- •Smokers (average daily smoking 5 or more); Subjects who consumed more than 15 grams of alcohol per day within one week prior to the screening;
- •Drug abusers or drug urine screening positive;
- •The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: DDO-3055 tablets；Placebo (Drug)
Treatment group B
Experimental
干预措施: DDO-3055 tablets；Placebo (Drug)
Treatment group C
Experimental
干预措施: DDO-3055 tablets；Placebo (Drug)
结局指标
主要结局
Number of Subjects with Adverse Events (AE)
时间窗: up to 14 days
次要结局
- Change of Ret from baseline(Day1, Day7, Day14)
- Peak plasma concentration (Cmax) on Day 1 and Day 7(Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose)
- Change of endogenous erythropoietin from baseline :Day 1 and Day 7(0, 24 hours post dose)
- Change of Hepcidin from baseline(Day1, Day 9)
- Time to maximum plasma concentration (Tmax) on Day 1 and Day 7(Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose)
- Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7(Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose)
- Change of VEGF from baseline :Day 1 and Day 7(0, 24 hours post dose)
- Change of Ferritin from baseline(Day1, Day 9)
- Change of Serum Iron from baseline(Day1, Day 9)
- Change of Hb from baseline(Day1, Day7, Day14)
研究者
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