A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of treatment-related adverse events as assessed by CTCAE 5.0
研究概览
简要总结
This is a Phase 1a, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (BMI) between 19.0 and 28.0 kg/m² inclusive, and whose routine semen analysis results during the screening period meet the criteria of a total sperm count of less than 180 million (or a sperm concentration of less than 63 million) or a percentage of progressively motility sperm of less than 56%.
- •Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four months after the end of administration, and must not have plans for pregnancy or sperm donation.
- •Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form.
排除标准
- •Participants with a history of severe diseases, including but not limited to conditions affecting the skeletal, neuropsychiatric, cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and reproductive systems (such as reproductive system infectious diseases, varicocele, reproductive tract obstruction, etc., except for oligoasthenzoospermia), as judged by the investigator, may endanger the safety of the participant or affect the study results.
- •Participants who have planned to receive treatments related to oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic kallikrein, within 3 months prior to screening or during the trial period.
- •Participants with a history of treatment with nerve growth factor-like drug therapy (such as mouse nerve growth factor for injection) within 3 months prior to screening.
- •Subjects who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- •Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged clinically significant by the investigator.
- •Subjects who are allergic to any component of the experimental drug or biological agent, or who, in the judgment of the investigator, are at risk of allergy as a result of participation in the study.
- •Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening).
- •Tattoos at the injection site or other skin conditions that interfere with observation of the skin.
- •Subjects who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
- •Subjects with frequent alcohol consumption within 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol by volume or 150 ml of wine); or those with a positive alcohol breath test.
- •Subjects who have habitual consumption of more than 5 cups of coffee, tea or cola, etc. per day (150 ml and above per cup) in the 3 months prior to screening.
- •Subjects who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.
- •Subjects who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have history of blood transfusion within 4 weeks prior to enrollment.
- •Subjects who have taken any investigational product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.
- •Vaccination within 1 month prior to screening or scheduled to be administered during the study period up to 2 months after completion of the study.
- •Subjects who have used any prescription, over-the-counter medications or herbal remedies within 14 days prior to screening.
- •Subjects with a history of fear of needles and homophobia.
- •Subjects with other factors that are not suitable for participation in this study as judged by the investigator.
研究组 & 干预措施
lowest dose group
8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)
干预措施: STSP-0902 injection (Drug)
lowest dose group
8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)
干预措施: Placebo (Drug)
low dose group
8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)
干预措施: STSP-0902 injection (Drug)
low dose group
8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)
干预措施: Placebo (Drug)
middle dose group
8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)
干预措施: STSP-0902 injection (Drug)
middle dose group
8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)
干预措施: Placebo (Drug)
high dose group
Experimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort)
干预措施: STSP-0902 injection (Drug)
high dose group
Experimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort)
干预措施: Placebo (Drug)
highest dose group
Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort)
干预措施: STSP-0902 injection (Drug)
highest dose group
Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment-related adverse events as assessed by CTCAE 5.0
时间窗: 28 days
To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects
次要结局
- apparent oral clearance (CL/F)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Elimination Phase Half-life (t1/2)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Anti-drug antibody(ADA)(Pre-dose; after dose: 336 hours, 28 days)
- Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Maximum Concentration (Cmax)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Area under the plasma concentration-time curve (AUC0-t)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Time to peak Concentration (Tmax)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)