An Open-label Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI After Single and Multiple Ascending Dose Administration to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The incidence of AEs and SAEs. Concentration of VM1500A in plasma and RBCs
研究概览
简要总结
To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers
详细描述
Primary Objective:
To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers.
Secondary Objectives:
To evaluate pharmacokinetic parameters of VM-1500A after its single and multiple intramuscular ascending dose administration to healthy volunteers.
To evaluate safety and tolerability of ELPIDA®, administered in the run-in period
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking healthy male subjects aged 18 - 45 years (inclusive);
- •Verified "healthy" status, based on standard clinical, laboratory, and instrumental examination methods;
- •Body weight ≥ 50 kg and Body Mass Index in the range from 18.5 to 30.0 kg/m2;
- •Signed the Participant Explanation Sheet and the Informed Consent Form;
- •Consent to use an adequate method of contraception throughout the study and 3 months after its completion: a condom with spermicide substance (cream, foam or suppository).
排除标准
- •Chronic cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal or gastrointestinal diseases, as well as immunologic, hepatic, renal, or blood diseases;
- •Laboratory abnormalities, or ECG abnormalities at Screening;
- •Systolic arterial pressure less than 90 mm Hg or above 130 mm Hg, diastolic arterial pressure less than 60 mm Hg or above 85 mm Hg, heart rate less than 60 BPM or more than 90 BPM at Screening;
- •Regular intake of drugs within 2 weeks before Screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver, kidney, or CNS function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) within 4 weeks before Screening;
- •Presence of antibodies to HIV or hepatitis C virus, presence of hepatitis В surface antigen, positive syphilis test;
- •Unstable sleeping (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
- •Signs of alcohol (taking more than 10 units of alcohol per week) or drug addiction; alcohol or drugs consumption within 7 days prior to Screening; smoking within 3 months before Screening; positive drug or alcohol test at Screening;
- •Depression episodes or other mental disorders/conditions in medical history that required therapy
- •Allergy in medical history (including drug intolerance and food allergy);
- •Hypersensitivity to the active substance or to any other ingredient of the study drug. Sucrose intolerance, sucrase-isomaltase deficiency, sucrose isomaltose malabsorption, lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- •Blood/plasma donation (450 ml or more of blood/plasma) or surgical intervention within 12 months before Screening;
- •Diseases and conditions (current or in medical history), including surgical intervention, which, according to the opinion of Investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug (excluding appendectomy);
- •Participation in other clinical studies or therapy with other study drugs within 3 months before Screening;
- •Acute infectious diseases within 4 weeks before Screening;
- •Subjects unable to read or write; unwillingness to understand and follow to the procedures, defined in the Study Protocol; non-compliance with the dosing regimen or procedures, which according to the opinion of Investigator, may affect the study results or safety of study subject and prevent the subject from further participation in the study; any other associated medical or serious mental conditions making the subject not eligible to participate in the clinical study, restricting validity of obtaining the informed consent or affecting the subject's ability to participate in the study.
研究组 & 干预措施
VM-1500A-LAI 600 mg Multiple
VM-1500A-LAI Multiple dose (2 injections every 4 weeks)
干预措施: VM-1500A-LAI (Drug)
VM-1500A-LAI 150mg
VM-1500A-LAI 150mg IM single dose
干预措施: VM-1500A-LAI (Drug)
VM-1500A-LAI 300mg
VM-1500A-LAI 300mg IM single dose
干预措施: VM-1500A-LAI (Drug)
VM-1500A-LAI 600mg
VM-1500A-LAI 600mg IM single dose
干预措施: VM-1500A-LAI (Drug)
VM-1500A-LAI 1200mg
VM-1500A-LAI 1200mg IM single dose
干预措施: VM-1500A-LAI (Drug)
结局指标
主要结局
The incidence of AEs and SAEs. Concentration of VM1500A in plasma and RBCs
时间窗: 4 weeks for SAD, 8 weeks for MAD
The incidence of adverse events (AEs) and serious adverse events (SAEs). This is an open-label study aimed to evaluate safety, tolerability, and pharmacokinetics of VM-1500A-LAI administered as single or multiple ascending doses to healthy volunteers.
次要结局
未报告次要终点