NCT05347758Unknown1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
Shandong Suncadia Medicine Co., Ltd.0 个研究点目标入组 106 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 106
- 主要终点
- Number of adverse Events
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;
- •Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
- •Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from screening to at least 6 months after the final dose of study drug;
- •Able and willing to provide written informed consent and to comply with the study protocol;
- •Physical examination, vital signs are normal or are judged not clinically significant by the investigator;
排除标准
- •Participants with any abnormal results and judged clinically significant by the investigator;
- •HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;
- •Abnormal ECG that is clinically significant, or QTcF >450 msec;
- •Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- •Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years;
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, history of pancreatitis or symptomatic gallbladder disease;
- •History of gastric emptying anomalies (gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer) ;
- •Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems;
- •Use any prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration;
- •Subject who received bariatric surgery or procedures, or use of weight-reducing drugs within 3 months prior to administration, or body weight change of more than ±10% within 3 months prior to administration;
- •Use any drugs that may affect glucose metabolism were used within 1 month before administration.
- •Suspected allergy to any ingredient in the study drug;
- •Participation in clinical trials of any drug or medical device within 3 months before screening;
- •History of regular alcohol consumption exceeding 14 drinks per week within 6 months before screening;
- •More than 5 cigarettes per day or cigarettes within 3 months before screening;
- •Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment;
- •Strenuous exercise in 48 hours before treatment;
- •Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
- •Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug;
- •Subjects can't tolerate venipuncture;
- •Subjects have special dietary requirements and cannot comply with the unified diet;
- •Other conditions judged by the investigator to be not suitable to participate in the trial;
研究组 & 干预措施
Group A
Experimental
Drug: HRS-7535
干预措施: HRS-7535 (Drug)
Group B
Placebo Comparator
Drug: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of adverse Events
时间窗: Day-2 to last follow-up
Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;
次要结局
- Pharmacokinetic (PK) profile of HRS-7535 - CL/F(pre-dose to 96 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - t1/2(pre-dose to 96 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t(pre-dose to 96 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞(pre-dose to 96 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Cmax(pre-dose to 96 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Tmax(pre-dose to 96 hours post-dose)
- PD profile of multiple doses of HRS-7535 - 5-points glucose profile(pre-dose up to 24 hours after the last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Vz/F(pre-dose to 96 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss(pre-last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss(pre- last doseto 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss(pre- last dose to 96 hours post- last dose)
- Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose(pre-dose to 24 hours post-dose)
- Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin(pre-dose to 24 hours post-dose)
- Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide(pre-dose to 24 hours post-dose)
- Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon(pre-dose to 24 hours post-dose)
- Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - DF(pre- last dose to 96 hours post- last dose)
- Pharmacokinetic (PK) profile of HRS-7535 - CLss/F(pre- last dose to 96 hours post- last dose)
- PD profile of multiple doses of HRS-7535 - HbA1c(pre-dose up to 96 hours after the last dose)
- Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine(pre-dose up to 96 hours after the last dose)
- PD profile of multiple doses of HRS-7535 - weight(pre-dose up to 96 hours after the last dose)
研究者
相似试验
已完成
1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy SubjectsHIV-1 InfectionNCT04802811Jiangsu HengRui Medicine Co., Ltd.37
已完成
1 期
Safety, Tolerability, Pharmacokinetics(PK), Pharmacodynamics(PD) and Food Effect of HRS9950 in Healthy and CHB SubjectsChronic Hepatitis bNCT04464733Jiangsu HengRui Medicine Co., Ltd.146
Unknown
1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B PatientsChronic Hepatitis BNCT04480294Jiangsu HengRui Medicine Co., Ltd.108
已完成
1 期
Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy SubjectsSARS CoV 2 InfectionNCT05523141Ascletis Pharmaceuticals Co., Ltd.72
已完成
1 期
A Phase I Study of SHEN26 Capsule in Healthy ParticipantsHealthy ParticipantsNCT05504746Shenzhen Kexing Pharmaceutical Co., Ltd.86