NCT05966701尚未招募1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalation Phase I Clinical Study of Humanized Monoclonal Antibody Injection (SSGJ-613) in Healthy Adult Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
研究概览
简要总结
To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
详细描述
The purposes of this study are to evaluate the safety and tolerability, PK characteristics and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
- •The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- •Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
排除标准
- •Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
- •Subjects who have or are currently suffering from any serious clinical diseases before screening,
- •Abnormal vital signs or abnormal ECGor physical examination are clinically significant
- •Clinical laboratory examinations found to be abnormal and have clinical significance
- •Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
- •Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
- •Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening
- •Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration
- •Has known or suspected pregnancy or lactation
- •Subjects who are unsuited to the study for any reason, judged by the investigators
研究组 & 干预措施
SSGJ-613
Experimental
SSGJ-613，SC
干预措施: SSGJ-613 (Drug)
Placebo
Placebo Comparator
Placebo, SC
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
时间窗: Up to Day 174
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc..
次要结局
- SSGJ-613 Concentration in Serum(Up to Day 174)
研究者
研究点 (1)
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