NCT05542303已完成1 期
A Single Ascending Dose, Safety, and Pharmacokinetic Study of ZB001 in Healthy Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
研究概览
简要总结
The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening
- •Free of any clinically significant disease or medical condition at screening as determinedby the Investigator
- •Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2
- •Women must be of non-childbearing potential:Surgically sterile; no menses for ≥ 12 months AND a follicle-stimulating hormone level>40 IU/L at screening; or meeting the definition of "postmenopausal range" based onscreening laboratory results
- •Willing and able to comply with all the study requirements and provide written informedconsent for the study
排除标准
- •Donated blood or experienced significant blood loss
- •Has inadequate venous access or unsuitable veins for venipuncture and IV administrationof the study drug
- •History of or have any evidence of diabetes mellitus
- •History of renal impairment or inflammatory bowel disease
- •History of clinically significant ear pathology, ear surgery, or hearing impairment
- •Active infection
- •History of malignancy
- •Have undergone a surgical procedure within 3 months prior to study entry or have anysurgical procedure anticipated to be required during the study.
- •Any clinically significant abnormality at screening that, inthe opinion of the Investigator, would exclude them from the study
- •Received the last dose of an investigational drug or treatment with a medical devicewithin 30 days or 5 half-lives prior to screening or currentlyparticipating in another study of an investigational drug or medical device
- •Previously participated in a study of IGF-1 or IGF-1R-related products
- •Any medical condition or laboratory abnormality, that in the opinion of the Investigator, would prevent the subject from completing the study, pose a risk to the subject, or confound the ability to interpret study results
研究组 & 干预措施
ZB001 for injection
Experimental
Treated different dose cohorts with single intravenous injection of ZB001
干预措施: ZB001 for injection (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
时间窗: during the study, up to 4 weeks
次要结局
- Serum ZB001 antidrug antibody (ADA) titers(Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks)
- ZB001 concentrations in the blood over time(Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks)
研究者
研究点 (1)
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