A Randomized, Double-blind, Placebo-controlled, Single/Multiple Ascending Dose, Phase 1 International Multi-center Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of RG002C0106 Injection in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage
详细描述
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage There are 5 cohorts for the SAD escalation scheme. Dose escalation will start with the planned lowest dose 25mg，and the highest dose will be mainly determined based on the data obtained during the study process.
There are 3 cohorts for the MAD stage .The doses for these 3 cohorts are low dose, medium dose, and high dose, respectively.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are able to communicate well with the investigator, understand and follow trial requirements, voluntarily participate in the trial, understand and sign Informed Consent Form (ICF);
- •Healthy adult subjects aged 18 to 60 years (inclusive), male or female;
- •BMI18-32 kg/m2 ;
- •Subjects who have no current or past medical history of clinically significant diseases of the circulatory system, digestive system, nervous system, respiratory system, and urinary system, mental disorders, or metabolic disorders or history of such disease; and whose physical examination, vital signs, electrocardiogram, chest X-ray or blood test and laboratory tests show normal results or abnormal but not clinically significant results (subject to clinical judgment) at the time of screening.
- •WOCBP must have a negative serum pregnancy test and must not be breastfeeding, lactating or planning pregnancy during the study period.
- •A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period.
- •Evidence of vaccination (medical record and/or positive antibody test) against Neisseria meningitidis infection (types A, C, W and Y and Group B), Streptococcus pneumoniae, and Haemophilus influenzae type b infection is required before initiation of the investigational drug or placebo.
排除标准
- •Known or persistent mental disorders that require medication intervention and may interfere with the subject's participation in the study.
- •Presence or suspicion of active viral, bacterial, fungal or parasitic infections;
- •History of recurrent or chronic infections;
- •History of epidemic meningococcal infection;
- •History of splenectomy or asplenia;
- •History of complement abnormalities or hereditary complement deficiencies;
- •Any skin conditions and/or tattoos that may interfere with the safety assessment of the injection site, or any relevant history of abdominal scar (surgery, burns, etc.);
- •Subjects who have tested positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and treponema pallidum antibody (optional );
- •Hepatic function abnormal.
- •Renal function abnormal.
- •Allergic condition (allergy to multiple drugs and food) or a known history of allergic reactions to oligonucleotides or hypersensitivity to subcutaneous injections;
- •Subjects who participate in other interventional clinical studies and receive interventional therapy within 30 days before the first dose of the study drug in this study or within the 5 half-lives of the study drug (including investigational drugs and investigational devices) in other interventional clinical studies, whichever is longer.
- •Subjects with history of drug abuse within 12 months.
- •Use of non-prescription drugs within 14 days prior to the first dose of the study drug or within the 5 half-lives of the non-prescription drugs (whichever is longer), unless the investigator determines that the medication is not clinically significant.
- •Subjects who have consumed more than 14 units of alcohol per week.
- •Heavy smoker.
- •Subjects who have donated or lost blood ≥ 480 mL within 3 months.
- •Subjects who have tested positive for pregnancy test; lactating women.
研究组 & 干预措施
RG002C0106
Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration
干预措施: RG002C0106 (Drug)
placebo
Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration
干预措施: RG002C0106 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
时间窗: up to 169 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
次要结局
未报告次要终点