NCT01525147已完成1 期
A Block-randomized, Double-blind, Placebo-controlled, Single-dose Escalating, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers
Yuhan Corporation2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2011年12月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Safety Evaluation
研究概览
简要总结
A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in healthy male volunteers
详细描述
First in human Study
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers of aged between 20 to 45 years old at the time of screening
- •Volunteers weighing over 50 kg with body mass index between 18.0 ~ 28.0 kg/m2
- •Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
排除标准
- •Have history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood•tumor, cardiovascular, urinary system, and mental disorder
- •Presence of current tuberculosis or latent tuberculosis or have history of tuberculosis (confirmed by chest X-ray test or tuberculin skin test)
- •Have active infection such as chronic or topical infection
- •Have history of hospitalization or have received antibiotics due to serious infection within 1 month prior to the first administration
- •Have know hypersensitivity to biologicals
- •Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit at the time of screening
- •Shown positive results in any of HBsAg, HCV Ab, HIV Ab tests
- •Have history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening
- •Received any biological drugs including monoclonal antibody products or protein drugs within the last 6 months prior to the first administration
- •Participated in any other clinical trials within 2 months prior to the first administration of Investigational Product
- •Have donated whole blood within 2 months prior to the first administration of Investigational Product, or donated blood components or received transfusion within 1 month prior to the first administration of Investigational Product
- •Subject who drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized
- •Smoker (Subject can be enrolled if he/she had quit smoking within 3 months before the first administration of Investigational Product (Day 1))
- •Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG)
结局指标
主要结局
Safety Evaluation
时间窗: Participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.
Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray
次要结局
- Pharmacokinetic Evaluation(PK sampling : participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.)
- Immunogenicity Evaluation(HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol.)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
1 期
Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult VolunteersCOVID-19NCT05429385Shanghai Henlius Biotech
已完成
1 期
A Study of HY209 in Healthy Male Volunteers for SepsisSepsisNCT04255979Shaperon40
Unknown
1 期
Phase 1 Single Dose Escalation Study of CTB-001HealthyNCT01647893HLB Pharmaceutical Co., Ltd.33
Unknown
1 期
Safety and Tolerability of TWP-201 in Healthy Female SubjectsInfertilityNCT04878705Shandong TheraWisdom Biopharma Co., Ltd.48
已完成
1 期
A Study of rhuMAb IFNalpha in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT00541749Genentech, Inc.60