NCT07355621已完成1 期
A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of UP-818-CC Injection in Healthy Chinese Subjects After Single-dose and Multiple-dose Intravenous Infusion
EnliTISA (Shanghai) Pharmaceutical Co., Ltd.0 个研究点目标入组 73 人开始时间: 2022年2月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
研究概览
简要总结
The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC.
This study is divided into two parts, single ascending dose part (SAD) and multiple ascending dose part (MAD), both conducted in healthy subjects, using a randomized, double-blind, placebo-controlled, dose-escalating design.
The SAD part is planned to be carried out in 6 dose groups. A total of about 43 healthy adult subjects are planned to be included. All subjects will receive a single dose on the first day (D1).
According to the obtained PK and safety information of the SAD, three appropriate dose groups are selected in MAD. A total of about 30 healthy adult subjects, both male and female, will be included. All subjects will receive multiple doses from D1 to D7, once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) in the range of 19 to 26, including boundary values, BMI = weight (kg) / height (m) 2;
- •The medical history, physical examination, laboratory items and tests related to the trial are all normal or abnormal and have no clinical significance, and the clinical research doctor judges that they are qualified;
- •During the trial and within 3 months after the trial, the subjects or their spouses voluntarily took effective contraceptive measures, such as abstinence, condoms, the use of intrauterine devices, double-barrier methods (such as condoms and contraceptive diaphragms), etc., female subjects enter the trial after confirming the menstrual period; male subjects have no sperm donation plan;
- •Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign written informed consent.
排除标准
- •Those who are allergic to any active ingredient of the investigational drug or any excipient or excipient;
- •Allergies (including bronchial asthma or asthmatic bronchitis, allergic rhinitis and other multiple drug or food allergies, etc.) or the total IgE results of the screening period showed allergies;
- •Those with past or current diseases that the investigator considers ineligible to enroll, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, genitourinary system, metabolism and bone, or those with a history of allergic diseases or malignant tumors;
- •Past or current chronic obstructive pulmonary disease, active pulmonary tuberculosis (including but not limited to increased erythrocyte sedimentation rate or a positive T-cell spot test for tuberculosis infection in the screening period or abnormal and clinically significant chest CT examination in the screening period, judged by the investigator afterwards, only those with calcifications and no clinically significant symptoms on lung imaging examinations can be enrolled) and other respiratory diseases;
- •Patients with acute infection within 2 weeks before screening;
- •Difficulty in venous blood collection, or those with a history of needle dizziness or haemorrhage;
- •Frequent excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 200 ml) in the 3 months prior to screening or ingestion of any food or drink containing caffeine, alcohol, xanthine or grapefruit within 48 hours prior to randomization;
- •History of binge drinking or frequent alcohol consumption within 6 months prior to the trial (more than 14 units of alcohol per week, 1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or alcohol breath test the day before dosing is positive (breath alcohol content > 0.0 mg/100 mL), or those who cannot abstain from alcohol during the test;
- •Those who have participated in any drug clinical trial and have taken the investigational drug within 3 months before screening;
- •Donate blood or lose ≥400 mL of blood within 3 months before screening (except for female menstrual blood loss), or plan to donate blood or blood components during the study or within 3 months after the end of the study;
- •Persons with a history of drug abuse/dependence or drug history within 1 year before screening, or those with positive drug abuse screening (screening items may include: morphine, THC, methamphetamine, DMD fetamine, ketamine and cocaine);
- •Those who smoked more than 5 cigarettes per day within 3 months before screening and those who could not smoke during the whole trial period;
- •Have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health products within 14 days before screening;
- •Post-vaccination within 4 weeks prior to the first dose of investigational drug or planned within 4 weeks after the last dose is discontinued, live vaccines including but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG Bacillus, typhoid vaccine, live COVID-19 vaccine, etc.;
- •During the screening period, the QTcF interval >450 milliseconds (msec) or the abnormal and clinically significant results of the 12-lead ECG;
- •During the screening period, the investigators determined that the vital signs were abnormal: systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <50 mmHg or ≥90 mmHg, or the body temperature, heart rate, pulse, respiration, blood oxygen saturation and other indicators exceeded the center normal value range and the investigator judges that the abnormality has clinical significance;
- •During the screening period, estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 by MDRD equation (Appendix 3);
- •Those who are positive for one or more of hepatitis B surface antigen, hepatitis C virus (HCV) antibody, syphilis antibody (TPPA) or human immunodeficiency virus (HIV) antibody;
- •Those who cannot communicate or cooperate with medical staff due to neurological, mental illness or language barriers;
- •The investigator believes that the subjects are not suitable to participate in the trial, or the subjects cannot participate in the trial due to their own reasons.
研究者
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