A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQF3250 Capsules in Healthy Adult Subjects After Single Administration and Escalating Doses
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
研究概览
简要总结
TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.
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
- 否
入选标准
- •Chinese subjects aged above 18 years old (including 18 years old) and below 55 years old (including 55 years old);
- •Those who voluntarily sign a written informed consent form before the trial, have a full understanding of the trial content, process and possible adverse reactions, can communicate well with the researcher, and understand and comply with the requirements of this study;
- •Women of childbearing potential should agree to use effective contraceptive measures during the study and for 6 months after the end of the study;
- •Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 20-40kg/m2 (including both ends of the cutoff);
排除标准
- •Pregnant and lactating women.
- •Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, anteroposterior chest X-ray, and abdominal ultrasound results during the screening period are abnormal and have clinical significance.
- •Those who have had or currently have diseases/abnormalities such as heart, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, blood, nerve or mental illness, or related chronic diseases, or acute diseases, and the researcher assesses that they are not suitable to participate in the trial:
- •Have active tuberculosis during the screening period, or be a close household contact of an untreated active tuberculosis patient.
- •Have a history of severe bacterial, fungal or viral infection within 2 months before randomization, requiring hospitalization with intravenous antibiotics or antiviral drug treatment;
- •Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;
- •Subjects with any bleeding or bleeding events ≥ Common Terminology Criteria (CTC) AE grade 3 within 4 weeks before the first dose;
- •Clinically significant infections occur during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, and require antibiotic or antiviral drug treatment.
- •Have a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, and generalized herpes zoster.
- •Use any systemic cytotoxic or systemic immunosuppressive drugs within 6 months before randomization or within the study period, or use any local cytotoxic or local immunosuppressive drugs within 4 weeks before randomization or within 5 half-lives (whichever is longer) or during the study period.
- •Have received any other biological agents on the market or under investigation within 3 months or 5 half-lives (whichever is longer) before randomization.
- •Have received a live vaccine within 4 weeks before randomization or plan to receive a live vaccine during the study.
- •Those who have undergone surgery within 4 weeks before randomization, or plan to have surgery during the study period.
- •Those who lost blood or donated more than 400 mL of blood within 4 weeks before randomization.
- •Taking any prescription drugs, non-prescription drugs and herbal medicines within 4 weeks before randomization, except vitamin products.
- •Those who have difficulty collecting blood and have a history of fainting from needles or bleeding.
- •Are allergic to any known ingredients of TQF3250 capsules, or have any history of severe drug allergy.
- •Those with a history of drug abuse or positive urine drug screening.
- •Those who smoke more than 5 cigarettes/day or use a considerable amount of nicotine or nicotine-containing products within 3 months before randomization, or who cannot stop using any tobacco products during the trial.
- •Those who have been alcoholics for a long time or who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) within 3 months before screening, or who cannot abstain from alcohol during the test, or who have a positive alcohol breath test.
- •Those who habitually consume too many caffeinated drinks or foods within 4 weeks before screening. Have consumed grapefruit, bitter orange and the juice of these fruits within 7 days before the first dose, or cannot stop consuming grapefruit, bitter orange and the juice of these fruits during the study;
- •Those who have special dietary requirements and cannot accept standard diet;
- •There are any other reasonable medical, mental or social reasons that the researcher believes to be unable to participate in this study.
- •Those who are unable to comply with the trial plan;
- •Those who participated in and used other clinical trial drugs within three months before the first medication;
研究组 & 干预措施
TQF3250 placebo
Placebo without drug substance.
干预措施: TQF3250 placebo (Drug)
TQF3250 capsule
Oral administration, the fasting administration group was administered once, and the food-influenced group was administered once per cycle, for a total of two cycles. Each cycle is 10 days.
干预措施: TQF3250 capsule (Drug)
结局指标
主要结局
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
时间窗: Up to 20 days
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs).
Number of participants with abnormal clinical laboratory test indicators
时间窗: Up to 20 days
Number of participants with abnormal clinical laboratory test indicators.
Changes in body temperature after using TQF3250 capsules
时间窗: Up to 24 hour
Evaluate changes in body temperature after using TQF3250 capsules
Tolerance assessment: 12-lead electrocardiogram
时间窗: Up to 20 days
Tolerance assessment: 12-lead electrocardiogram
Changes in pulse/heart rate after use of TQF3250 capsules
时间窗: Up to 24 hour
Changes in pulse/heart rate after use of TQF3250 capsules
Changes in respiratory rate after using TQF3250 capsules
时间窗: Up to 24 hour
Evaluate changes in respiratory rate after using TQF3250 capsules
Changes in blood pressure after using TQF3250 capsules
时间窗: Up to 24 hour
To evaluate the changes in blood pressure after using TQF3250 capsules
Changes in blood oxygen saturation after using TQF3250 capsules
时间窗: Up to 24 hour
Evaluate changes in blood oxygen saturation after using TQF3250 capsules
次要结局
- Peak drug concentration (Cmax)(Within 20 days after administration)
- To evaluate the AUC0-∞ of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial(Up to 20 days)
- Peak time (Tmax)(Within 20 days after administration)
- Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)(Within 20 days after administration)
- Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)(Within 20 days after administration)
- To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial(Up to 20 days)
- Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites(Up to 20 days)
- Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial(Up to 20 days)