NCT07736391进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of SYH2069 Injection in Healthy Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as accessed by CTCAE v6.0
研究概览
简要总结
To evaluate the safety and tolerability of single and multiple doses of SYH2069 Injection in healthy participants.
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
- •Fully understand the content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form before the trial;
- •Male or female, aged 18-55 years (inclusive, based on the time of signing the informed consent form) at screening;
- •At screening, male body weight ≥ 50 kg, female body weight ≥ 45 kg, SAD study: BMI between 19 and 28 kg/m2 inclusive), MAD study: BMI between 24 and 35 kg/m 2 inclusive);
- •Subjects (including partners) have no plans to have children from the time of signing the informed consent form until 6 months after the last dose, and agree to use highly effective contraceptive measures specified in the protocol.
排除标准
- •Known or suspected allergies to GLP-1 or GIP receptor agonists or any components of the investigational product, or allergic constitution (allergies to multiple drugs and foods);
- •Abnormal results of vital signs, physical examination, laboratory tests, chest X-ray, ultrasound, and electrocardiogram, etc., which are judged by the investigator to be clinically significant and unsuitable for participation in the study. Among them, the following conditions were not excluded in the MAD study: (1) systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg; (2) TG ≤ 3.42 mmol/L, TC ≤ 7.75 mmol/L (regardless of whether LDLC is abnormal), and abnormal HDLC; (3) ALT < 2 times × upper limit of normal, AST < 2 times × upper limit of normal, GGT < 2.5 times × upper limit of normal, total bilirubin < 1.5 times × upper limit of normal; (4) Blood uric acid <480 μmol/L and never accompanied by physiological abnormalities (gout, etc.); (5) Ultrasound shows fatty liver and excludes causes other than metabolism;
- •Meet any of the following at screening: (1) HbA1c > upper limit of normal, or fasting blood glucose ≤ 3.9 mmol/L or ≥ 6.1 mmol/L; (2) Calcitonin ≥ 50 ng/L; (3) eGFR < 90 mL/min/1.73m 2; (4) TSH exceeds the normal reference range;
- •Patients with prolonged QT/QTc interval at screening (QTcF > 450 ms), or have a history of risk factors for torsades de pointes (such as family history of heart failure/cardiomyopathy or long QT syndrome), or are taking concomitant medications that prolong the QT/QTc interval;
- •Those who are positive for any of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody;
- •History or presence of major cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune or nervous system diseases;
- •Subjects with severe trauma or major surgery within 6 months prior to screening, or planned to undergo surgery during the trial;
- •Patients with thyroid nodules diagnosed as C-TIRADS category 3 or above in the past or during the screening period;
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or history of pancreatitis or acute or chronic gallbladder disease;
- •Those with a history of malignant tumors, mental illness, depression, anxiety, or epilepsy;
- •History of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer);
- •Previous gastrointestinal surgery leading to malabsorption, or long-term use of drugs that have a direct effect on gastrointestinal motility. e.g., bariatric surgery or procedures (e.g., gastric banding), or use of GLP-1 or GIP receptor agonists or drugs or products that, in the opinion of the investigator, may cause weight change and affect weight assessment within 3 months prior to dosing.
- •Body weight change ≥ 5% within 3 months prior to screening (inclusive) (only applicable to MAD study；
- •Those who have symptoms such as dermatitis or skin abnormalities at and around the administration site;
- •Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 2 weeks before screening;
- •Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month before screening;
结局指标
主要结局
Number of participants with treatment-related adverse events as accessed by CTCAE v6.0
时间窗: SAD: Screening period up to day 29 MAD: Screening period up to day 50
after single and multiple doses
次要结局
- Maximum plasma concentration (Cmax)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Area under the concentration time curve from time 0 to infinity (AUCinf)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Percent of AUC extrapolated to infinity (AUC_Extrap)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Time to maximum concentration (Tmax)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Elimination half-life (t1/2)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Apparent volume of distribution (Vz/F)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Apparent clearance (CL/F)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Anti-SYH2069 antibody (ADA)(SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.)
- Mean change in plasma glucose from baseline(SAD: Baseline up to Day 29 MAD: Baseline up to Day 50)
- Mean change in insulin from baseline(SAD: Baseline up to Day 29 MAD: Baseline up to Day 50)
- Mean change in C-peptide from baseline(SAD: Baseline up to Day 29 MAD: Baseline up to Day 50)
- Mean change in glucagon from baseline(SAD: Baseline up to Day 29 MAD: Baseline up to Day 50)
- Mean change in HbA1c from baseline(MAD: Baseline up to Day 50)
- Change in body weight from baseline(MAD: Baseline up to Day 50)
- Change in waist circumference from baseline(MAD: Baseline up to Day 50)
- Mean change in Total Cholesterol(TC) from baseline(MAD: Baseline up to Day 29)
- Mean change in Triglycerides(TG) from baseline(MAD: Baseline up to Day 29)
- Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline(MAD: Baseline up to Day 29)
- Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline(MAD: Baseline up to Day 29)
- Change in blood pressure from baseline(MAD:Baseline up to Day 50)
- Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)(MAD: Baseline up to Day 29)
- Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)(MAD: Baseline up to Day 29)
- Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)(MAD: Baseline up to Day 29)
- Corrected QT(QTc) interval(SAD: Pre-dose at day 1 to day 8 MAD: Pre-dose at day 1 to day 29)
研究者
研究点 (1)
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