NCT06158737已完成1 期
A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年5月10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
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects will be enrolled in the experiment, 8 in each group.They will be randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subject understands and voluntarily signs a written informed consent form (ICF).
- •Healthy male or female subjects aged 18-45 years (inclusive) at the time of signing informed consent.
- •The body mass index (BMI) at screening was in the range of 18.5~28.0kg/m2 (inclusive).
- •Female subjects must meet the following conditions: no fertility (e.g. documented hysterectomy, bilateral transfusion;
- •Blood pregnancy detection knot during ovular tubule resection or ligation, or menopause for more than 1 year), or screening of fertile persons' results were negative, and they were willing to use strict and effective contraceptive methods (such as medication or barrier methods) during the study period.
- •Male subjects were required to consent to a strict and effective form of contraception.
- •· Subjects are willing and able to complete the procedures and examinations associated with the trial, and can maintain a stable diet, exercise and ohter lifestyle habits during the trial.
排除标准
- •Subjects' forearm skin could not be stimulated by capsaicin, or was unresponsive or abnormally responsive to capsaicin stimulation.
- •There is medical history or clinical evidence that the subject has a serious acute or chronic illness (including, but not limited to:
- •Heart, kidney, nerve, endocrine, blood, immune, infection, metabolic dysfunction, etc.), by investigator judged that participating in the study could confound the results or put the subjects at risk.
- •There is obvious concomitant disease, or physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, and electrocardiogram which reveals any clinically significant abnormalities, discomfort or disease. According to the researchers, it is not in line with clinical practice.
- •There is a history of malignancy, except for carcinoma in situ that has been completely resected surgically.
- •Drug abuse or alcohol dependence within the last 1 year.
- •A known history of HIV and/or syphilis infection, or a positive test for HIV and/or syphilis antibodies at screening;
- •Known history of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection, or hepatitis B surface at the time of screening
- •Antigen (HBsAg) and/or hepatitis C antibody positive.
- •Had undergone abdominal surgery or endoscopic intestinal surgery within 6 months prior to randomization.
- •Had undergone major surgical treatment within 6 months prior to randomization.
- •Had received hospitalization within 3 months prior to randomization.
- •Blood donation or blood loss ≥300ml in the 3 months prior to randomization.[17] Previously received drugs that target CGRP or CGRP receptors.
- •Use of any therapeutic or investigational biologics in the 6 months prior to randomization.
- •Participated in any of the trial drug interventions within 3 months or 5 half-lives (whichever is older) prior to randomization
- •The clinical study.
- •· Had used any prescription drugs or drugs within 30 days prior to randomization or 5 half-lives, whichever is older
- •Remedies, including Chinese herbs, vitamins and dietary supplements (hormones used in contraception for women of childbearing age)
- •Except for birth control pills).
- •Received live vaccine within 30 days prior to randomization.
- •A history of allergy to biological agents, including monoclonal antibodies.
- •A history of severe allergies to food, drugs, insect bites, etc.
- •Pregnant and lactating women.
- •Any other situation in which the investigator deems it inappropriate to participate in the study, such as the subject having potential compliance problems; Unable to complete all inspections and evaluations as required by the programme
研究组 & 干预措施
Experimental: JS010 injection
Experimental
干预措施: JS010 injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: up to 168 days post-dose
Incidence and severity of adverse events (AE) and serious adverse events (SAE) , as well as abnormalities in vital signs, electrocardiogram and laboratory tests.
次要结局
- Anti-drug antibodies (ADA)(up to 168 days post-dose)
- Time to Maximum Plasma Concentration (Tmax)(up to 168 days post-dose)
- Peak Plasma Concentration (Cmax)(up to 168 days post-dose)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(up to 168 days post-dose)
- Terminal Elimination Half-Life (t1/2)(up to 168 days post-dose)
- Cutaneous blood flow(up to 168 days post-dose)
研究者
研究点 (1)
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