NCT05559125终止1 期
An Open-label, Single-ascending Dose Phase I Study to Evaluate the Safety and Tolerability of STSA-1002 Combined With STSA-1005 in Healthy Subjects
Staidson (Beijing) Biopharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
研究概览
简要总结
An open-label, single-ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 combined with STSA-1005 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Healthy subjects, aged ≥ 18 but ≤ 45, male and female;
- •Weight: Male≥50.0kg, Female ≥ 45kg; Body mass index: 19.0-26.0 kg/m2, inclusive;
- •Subjects (including their partners) must take effective contraceptive measures and have no birth plan or sperm or egg donation plan during the trial period and within 6 months after the end of the last administration;
- •The subjects were aware of the risks of the trial, voluntarily participated in the study and signed the informed consent form (ICF).
排除标准
- •Have a history of serious disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular diseases) or have undergone any major surgery within 2 months prior to screening;
- •The investigators determined that abnormalities in pre-enrollment physical examinations, laboratory tests, and trial-related tests were clinically significant;
- •A definite history of food or drug allergies;
- •Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
- •History of tuberculosis; or combined with T-SPOT.TB results, low-dose chest CT comprehensive evaluation of tuberculosis infection;
- •Hemoglobin was lower than the lower limit of normal value during the screening period;
- •Smoking more than 5 or equivalent cigarettes per day in the 3 months before screening;
- •Regular drinkers in the 6 months prior to screening, i.e. those who have consumed more than 2 units of alcohol per day (1 unit =360ml beer or 45ml spirits with an alcohol concentration of 40% or 150ml wine) in the 6 months prior to screening or have a positive alcohol test result;
- •Subjects with a history of substance abuse within 1 year before screening or have a positive drug test result;
- •Blood loss or blood donation > 400ml three months before screening, or blood transfusion history within 4 weeks before inclusion;
- •Participate in clinical trials of new drugs or vaccines as a subject within 3 months prior to screening；
- •Vaccination was given within 1 month before screening or planned between the study period and 2 months after the end of the study;
- •Use of medications that may affect immune function in the 6 months prior to screening or any monoclonal antibody or biologic treatment in the 3 months prior to screening and use of prescription drugs/over-the-counter drugs or herbal medicines in the 14 days prior to screening；
- •Drink more than 5 cups of coffee, tea or cola (150ml or more per cup) daily within 3 months before screening;
- •Pregnant or lactating women;
- •A history of blood and needle sickness；
- •Other circumstances in which the investigator considers it inappropriate to participate in the study.
研究组 & 干预措施
STSA-1002 and STSA-1005 dose level 1
Experimental
干预措施: STSA-1002 Injection (Drug)
STSA-1002 and STSA-1005 dose level 1
Experimental
干预措施: STSA-1005 Injection (Drug)
STSA-1002 and STSA-1005 dose level 2
Experimental
干预措施: STSA-1002 Injection (Drug)
STSA-1002 and STSA-1005 dose level 2
Experimental
干预措施: STSA-1005 Injection (Drug)
STSA-1002 and STSA-1005 dose level 3
Experimental
干预措施: STSA-1002 Injection (Drug)
STSA-1002 and STSA-1005 dose level 3
Experimental
干预措施: STSA-1005 Injection (Drug)
STSA-1002 and STSA-1005 dose level 4
Experimental
干预措施: STSA-1002 Injection (Drug)
STSA-1002 and STSA-1005 dose level 4
Experimental
干预措施: STSA-1005 Injection (Drug)
结局指标
主要结局
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
时间窗: 56 days
To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects.
次要结局
- Maximum plasma concentration (Cmax).(Up to 1344hours postdose)
- Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t).(Up to 1344 hours postdose)
- Elimination rate constant (Kel).(Up to 1344 hours postdose)
- Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF).(Up to 1344 hours postdose)
- Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).(Up to 1344 hours postdose)
- Apparent volume of distribution (Vz).(Up to 1344 hours postdose)
- Mean residence time (MRTlast).(Up to 1344 hours postdose)
- Extrapolated area under the curve (AUC_%Extrap).(Up to 1344hours postdose)
- Change from baseline in concentration of free C5a and anti-drug antibody.(Up to 1344 hours postdose)
- Time of maximum concentration (Tmax)(Up to 1344hours postdose)
- Elimination half-life (t1/2).(Up to 1344 hours postdose)
- Clearance (CL).(Up to 1344 hours postdose)
研究者
研究点 (1)
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