NCT07719257尚未招募1 期
A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TUL108 for Injection After Single and Multiple Intravenous Infusions in Healthy Participants.
Zhuhai United Laboratories Co., Ltd.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年7月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
详细描述
Primary Objective:
To evaluate the safety and tolerability of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Secondary Objectives:
- To evaluate the pharmacokinetic (PK) profiles of TUL108 following single and multiple IV infusion in healthy participants.
- To evaluate the effect of IV infusion of TUL108 on QT interval.
- To preliminarily evaluate the human biotransformation and mass balance characteristics following IV infusion of TUL108.
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
- Double (Participant, 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
- •Participants must sign the informed consent form prior to the study, fully understand the study, procedures, and potential adverse reactions, and be voluntary participate in and able to complete the study as required by the protocol.
- •Male or female participants aged 18-45 years (inclusive).
- •Body weight of not less than 50.00 kg for male participants and 45.00 kg for female participants with body mass index (BMI) within the range of 19.0-27.0 kg/m2 (inclusive).
- •Female participants of childbearing potential, or male participants whose partners are of childbearing potential, must have no plans for pregnancy, sperm/egg donation from signing the informed consent until 3 months after the last dose, and must be voluntary to use highly effective contraception (including their partners) (non-pharmacological contraception is required during the study).
排除标准
- •Having a clinically significant severe disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, pulmonary, immunological, psychiatric, or cardiovascular and cerebrovascular diseases) within 12 months prior to screening.
- •Participants with clinically significant abnormalities in laboratory tests, physical examination, vital signs, electrocardiogram (ECG), posteroanterior chest X-ray, or abdominal ultrasound.
- •Female participants who are pregnant or lactating.
- •Participants with acute illness or requiring concomitant medication from screening to the first dose.
- •Participants who are unable to tolerate venipuncture or have a history of needle phobia or hemophobia.
- •Participants who are unsuitable for the study as assessed by the investigator due to any other factors.
结局指标
主要结局
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
时间窗: Day 1 to Day 4
Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
时间窗: Day 1 to Day 11
次要结局
未报告次要终点
研究者
研究点 (1)
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