SSS40 A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study of Single-dose, Dose-escalation Safety, Tolerability, Pharmacokinetics, and Immunogenicity in Healthy Chinese Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 69
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a single-center, randomized, double-blind, single-administration, escalating-dose, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of SSS40 in healthy subjects in China.
A total of 8 subcutaneous dose groups were planned, including 1mg, 3mg, 10mg, 20mg, 30mg, 45mg, 60mg, 80mg. Starting from the 10mg group, a sentinel approach was adopted, whereby 2 subjects were first enrolled in the group, and randomized to the sentinel group in a 1:1 ratio (test drug:placebo), with the sentinels blinded, and then the remaining subjects in the group were randomized according to a 1:1 ratio (test drug:placebo), and the sentinel group was blinded. After completion of the 72-h safety assessment in the sentinel group, the remaining subjects in the group were randomized to receive the drug according to the test drug group and the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Signed an informed consent form prior to the trial, volunteered to participate in the trial, and was willing and able to follow the study protocol for medications, tests, visits, and other related procedures;
- •At the time of signing the informed consent form, the age of 18-45 years old (including both sides of the border), the proportion of female subjects is not less than 1/3 of the sample in the group;
- •Men weighing not less than 50kg and women weighing not less than 45kg, with BMI within the range of 19.0~26.0 (both sides included) [BMI=Weight (kg)/Height (m2)]；
- •Those who have no abnormalities or whose abnormalities are not clinically significant after assessment of vital signs, physical examination, routine blood, urine, blood biochemistry, coagulation, pregnancy test (women of childbearing age), 12-lead electrocardiogram (ECG), abdominal B-ultrasound, and thyroid function at the time of screening;
- •Subjects and their spouses or partners do not plan to have children or donate sperm/eggs and are willing to use reliable contraception or are not of childbearing potential from the time of initiation of study drug use (14 days prior to study drug use for females) through 6 months post-dose. The female subject is not lactating and has a negative pregnancy test.
排除标准
- •Prior history of allergies or sensitivities；
- •Diseases or factors with abnormal clinical manifestations, including, but not limited to, neurological, cardiovascular, hematologic, hepatic cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors. other factors；
- •History of bone or joint disease, including but not limited to osteoarthritis, avascular necrosis, destructive joint disease, pathologic fractures, osteonecrosis, rheumatoid arthritis, lupus erythematosus or arthritis, pathologic fractures, osteonecrosis, rheumatoid arthritis, neuropathic arthritis, lupus erythematosus, or Inflammatory Joint Diseases；
- •History of joint-related events, including but not limited to joint trauma, total joint replacement, meniscus or knee ligament injury (with or without surgical repair), joint infection, joint dislocation total joint replacement, meniscus or knee ligament injuries (with or without surgical repair), joint infections, joint dislocations etc.
- •Those with a history of clinically significant peripheral neuropathy, sensory abnormalities, and dullness of sensation；
- •Those with a history of autonomic neuropathy or diabetic neuropathy；
- •Those who have undergone surgery within 3 months prior to screening or are scheduled for surgery during the trial period；
- •Use of any prescription drugs, over-the-counter drugs, and supplements within 2 weeks prior to screening；
- •Average daily smoking ≥5 cigarettes or equivalent in the 3 months prior to screening；
- •Average weekly alcohol consumption in the 3 months prior to screening of more than 14 Alcohol Units (1 Alcohol Unit is equivalent to. 360 ml of beer or 45 ml of 40% alcohol by volume spirits or 150 ml of red wine) or a positive breath alcohol result Positive；
- •Those vaccinated within 4 weeks prior to screening or scheduled to be vaccinated during the study or within 4 weeks of the end of the trial；
- •Those who have participated in a clinical trial of any drug and used the test drug within 3 months prior to screening；
- •Participated in blood donation or large blood loss (≥200 ml) within 3 months before screening；
- •Those with known factors that significantly interfere with normal venous blood collection, such as a history of needle or blood fainting；
- •Those with a positive urine drug screening test；
- •Persons with a known history of substance abuse and/or drug intake.
研究组 & 干预措施
1mg dose group
The 1mg dose group is a low dose group and only safety and tolerability will be evaluated, pharmacokinetics and immunogenicity will not be evaluated, therefore one subject is planned to be enrolled.1mg SSS40 was injected subcutaneously on day1.
干预措施: SSS40 (Drug)
3mg dose group
Four subjects were included in the 3mg dose group (trial group: 3:1 placebo group).3mg SSS40/Placebo was injected subcutaneously on day1.
干预措施: SSS40 (Drug)
3mg dose group
Four subjects were included in the 3mg dose group (trial group: 3:1 placebo group).3mg SSS40/Placebo was injected subcutaneously on day1.
干预措施: Placebo (Drug)
10mg、20mg、30mg、 45mg、60mg or 80mg dose group
Sentinel dosing was used starting with the 10 mg group, with two subjects first enrolled and randomized 1:1 (test drug:placebo) for sentinel dosing, with sentinels participating in blinding, and then after the sentinel group had completed the 72-h safety assessment, the rest of the subjects in the group were randomized to receive dosing according to the test drug group versus the placebo group.10mg、20mg、30mg、 45mg、60mg or 80mg SSS40/Placebo was injected subcutaneously on day1.
干预措施: SSS40 (Drug)
10mg、20mg、30mg、 45mg、60mg or 80mg dose group
Sentinel dosing was used starting with the 10 mg group, with two subjects first enrolled and randomized 1:1 (test drug:placebo) for sentinel dosing, with sentinels participating in blinding, and then after the sentinel group had completed the 72-h safety assessment, the rest of the subjects in the group were randomized to receive dosing according to the test drug group versus the placebo group.10mg、20mg、30mg、 45mg、60mg or 80mg SSS40/Placebo was injected subcutaneously on day1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: up to 57 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Peak Plasma Concentration (Cmax)
时间窗: up to 57 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: up to 57 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: up to 57 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
次要结局
未报告次要终点
研究者
Cao Yu
Director of Clinical Trials Center of Affiliated Hospital of Qingdao University
The Affiliated Hospital of Qingdao University