NCT06232902已完成1 期
A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
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
- 84
- 试验地点
- 1
- 主要终点
- AUC0-∞
研究概览
简要总结
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers.
Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 groups.
详细描述
This is a phase I,single center, randomized, double-blind and parallel group clinical trial .
The primary objective is to assess the pharmacokinetic similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.
Subjects would receive a single 100mg（4ml） of QL1101or EU-Avastin® injection.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who voluntarily sign the written ICF;
- •Males aged 18- 50 years(inclusive).
- •Body weight between 50.0 kg and 90.0 kg (inclusive), body mass index (BMI) between 18.0 kg/m2 and 28.0 kg/m2 (inclusive);
- •Subjects who agree to practice effective contraception (including but not limited to physical contraception, surgery, or abstinence) throughout the study period until at least 6 months after study drug administration; See Appendix 3 for details;
- •Subjects with no disease history or with a previous medical history which is not clinically significant or has no influence on the study as determined by the study doctor.
排除标准
- •Subjects who have previously suffered or are currently suffering from any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, haematology, immunology and metabolic abnormalities or any other diseases that can interfere with the test results;
- •Abnormalities in clinical laboratory tests, preoperative infectious markers, Chest X-ray, 12-lead ECG, physical examination, vital signs, Abdominal ultrasound were clinically significant or judged to have an impact on the study (based on the judgment of the clinical study doctor);
- •History of hereditary bleeding, thrombophilia, thrombosis (eg, cerebral thrombosis, arteriovenous thrombosis), or history of non-traumatic bleeding and appropriate treatment, or any other condition that may predispose the subject to increased risk of bleeding or thrombosis (eg, thrombocytopenia, or INR > 1.5, etc.);
- •Hypersensitivity to the investigational products or any component of the investigational products, history of specific allergy (Recurrent asthma, urticaria, eczema, etc.) or allergic constitution (such as two or more drugs, food such as milk and pollen allergy);
- •Subjects with a history of gastrointestinal perforation, gastrointestinal fistula or any fistula or inflammatory bowel disease;
- •Recent infection requiring systemic anti-infective treatment within 28 days or serious infection (hospitalization and/or requiring intravenous antibiotics) within 6 months before administration of investigational product;
- •Subjects who have received surgical operation or bone fracture within 4 weeks before screening, or plan to receive surgical operation during the study;
- •One of the HBsAg, hepatitis C antibody, HIV antibody or Treponema pallidum antibody were tested positive;
- •Subjects who have taken any medicine or healthcare product (including Chinese herbal medicine) within 14 days before administration of investigational product;
- •Subjects who have received any biological products or live virus vaccines within 3 months or monoclonal antibodies within 9 months before the study treatment, or bevacizumab or VEGF targeted agents (such as aflibercept, ranibizumab, Conbercept, etc.) before administration of investigational product;
- •Subjects who have participated in the clinical study and administered the investigational product within 3 months before administration of investigational product;
- •Blood donors within 3 months before administration of investigational product;
- •Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day;
- •Subjects who are addicted to smoking or smoke more than 5 cigarettes per day in the 3 months before screening;
- •Alcoholics or regular drinkers within 6 months before screening, defined as drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- •Drug abusers or those who have used soft drugs (such as marijuana) 3 months before screening or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before screening;
- •Urine drug screening and breath test for alcohol was tested positive before administration of investigational product;
- •Subjects who may not be able to complete this study for other reasons or should not be included in the investigator's opinion.
研究组 & 干预措施
QL1101
Experimental
QL1101, intravenous infusion 90 min (±5min), D1 (Day 1, single dose)
干预措施: QL1101 (Drug)
Avastin®
Active Comparator
Avastin®, intravenous infusion 90 min (±5min), D1 (Day 1, single dose)
干预措施: Avastin® (Drug)
结局指标
主要结局
AUC0-∞
时间窗: 99 day
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single intravenous infusion in healthy volunteers
Cmax
时间窗: 99 day
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single
次要结局
- Vd(99 day)
- (AUC0--∞ -AUC0-t)/（AUC0--∞×100%)(99 day)
- AUC0-t(99 day)
- Tmax(99 day)
- t1/2(99 day)
- CL(99 day)
- the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0(99 day)
- immunogenicity(99 day)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy AdultsTumorNCT06371534Qilu Pharmaceutical Co., Ltd.228
招募中
1 期
A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy AdultsTumorNCT06173011Qilu Pharmaceutical Co., Ltd.168
Unknown
1 期
Comparing the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Males.Healthy MalesNCT04234594Qilu Pharmaceutical Co., Ltd.94
已完成
3 期
Efficacy and Safety of QL1012 in Women for Assisted Reproductive TreatmentInfertilityNCT05149924Qilu Pharmaceutical Co., Ltd.354
已完成
1 期
To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male SubjectsHealthy VolunteersNCT03390673Prestige Biopharma Limited119