A Phase 1, Prospective, Randomized, Double blind, Parallel, Placebo-controlled, Single period, Multiple dose study to evaluate safety and tolerability of Anti-PCSK9 Product (ZRC-3306) administered subcutaneously in healthy adult human subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence, severity & relationship of treatment emergent adverse events (of anti-PCSK9 product) investigational product during the study
研究概览
简要总结
Increasedlevels of lipids (hyperlipidemia), particularly low-density lipoproteincholesterol (LDLc) is considered the major risk factor for developingatherosclerotic plaques, causing a variety of cardiovascular events. Anti-PCSK9Product (ZRC-3306) is a PCSK9 inhibitor which regulates the levels of LDLreceptors that are responsible for the uptake and clearance of cholesterol fromthe blood. This Phase I prospective randomised, double-blind, placebo-controlledstudy will evaluate the safety and tolerability of anti-PCSK9 productadministered subcutaneously in healthy human volunteers.Increasedlevels of lipids (hyperlipidemia), particularly low-density lipoproteincholesterol (LDLc) is considered the major risk factor for developingatherosclerotic plaques, causing a variety of cardiovascular events. Anti-PCSK9Product (ZRC-3306) is a PCSK9 inhibitor which regulates the levels of LDLreceptors that are responsible for the uptake and clearance of cholesterol fromthe blood. This Phase I prospective randomised, double-blind, placebo-controlledstudy will evaluate the safety and tolerability of anti-PCSK9 productadministered subcutaneously in healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and non-pregnant, non-lactating female subjects aged 18 to 65 years at screening (Both inclusive).
- •Body mass index between 18.5 to 29.9 kg/m2 (Both inclusive) at screening.
- •Ability to communicate effectively with study personnel.
- •Be able to give consent for participation in the trial.
- •Normal health as determined by personal medical/surgical history, physical examination, ECG and laboratory assessment data during screening (within the clinically acceptable range).
- •Serum LDL level of ≤129 mg/dL at screening.
- •Female subjects with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) and be willing and able to continue contraception till study completion after administration of study treatment.
- •Male subjects must agree to use adequate contraception methods during the study and be willing and able to continue contraception till study completion after administration of study treatment.
- •Must be willing and able to communicate and participate in the whole study.
- •Subject should be literate to understand study requirement.
排除标准
- •History of alcohol consumption or tobacco use or drug abuse within past 1 year of enrollment or subject currently taking alcohol and/or tobacco products.
- •Presence or history of any of the disorder/disease within the past 3 months that might have impact on the clinical trial as per the investigator’s discretion i.e., cardiovascular, nervous system, gastrointestinal, respiratory or any other major disorder
- •History or presence of diagnosed or treated for allergic reaction to diphtheria toxin.
- •Difficulty with donating blood.
- •Systolic blood pressure more than 140 mmHg or lesser than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg.
- •Pulse rate less than 60/minute or more than 100/min.
- •Any clinically significant laboratory or ECG finding during screening as per discretion of investigator.
- •Any vaccine administration within 90 days from drug administration and who are planning to take vaccine during study period
- •Surgery within last 3 months or planned major surgery during the study period
- •Any major illness during last 3 months as per investigator’s discretion
- •Subject who have participated in drug research study within past 3 months.
- •Subject who have donated one unit (350 ml) of blood in past 3 months.
- •Use of any over the counter, any prescription medications or alternative tradition of medicine (Herbal medicines, homeopathy, siddha, Unani, etc.) within the 14 days prior to receiving study drug that might have impact on the clinical trial as per investigator’s discretion.
- •History or presence of diagnosed or treated food or known drug allergies or history of anaphylaxis or other severe allergic reaction.
- •Subject who are found positive urine alcohol test and urine test of drug of abuse
- •For female subjects, positive serum β-hCG level or urine pregnancy test at the screening or check-in visit.
- •Female subjects with history of pregnancy or lactation in the past 3 months.
结局指标
主要结局
incidence, severity & relationship of treatment emergent adverse events (of anti-PCSK9 product) investigational product during the study
时间窗: Baseline & Day 388
次要结局
- To assess Percentage of PCSK9-LDL-R interaction inhibition.(Baseline & Day 388)
- To assess the LDL lowering activity of anti-PCSK9 product(Baseline & Day 388)
- To assess the level of antibodies against anti-PCSK9 product.(Baseline & Day 388)