A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 3
- 主要终点
- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
研究概览
简要总结
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
详细描述
This is a three-part randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent before any assessment is performed.
- •Part A (HV):
- •Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.
- •Parts B & C (CKD)
- •Male and female participants 18 to 65 years of age.
排除标准
- •Women of childbearing potential.
- •Sexually active males unwilling to use contraception.
- •Part A (HV):
- •Clinically significant abnormal blood pressure, defined as SBP <90 mmHg or >140 mmHg or DBP <55 mmHg or >95 mmHg.
- •Abnormal resting HR, defined as <45 bpm or >90 bpm.
- •Part B & C (CKD)
- •History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.
- •Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.
- •History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part A: OJR520 dose A4
Participants will receive OJR520 dose level A4.
干预措施: OJR520 (Drug)
Part A: OJR520 dose A5
Participants will receive OJR520 dose level A5.
干预措施: OJR520 (Drug)
Part A: OJR520 dose A6
Participants will receive OJR520 dose level A6.
干预措施: OJR520 (Drug)
Part A: OJR520 dose A2
Participants will receive OJR520 dose level A2.
干预措施: OJR520 (Drug)
Part A: OJR520 dose A1
Participants will receive OJR520 dose level A1.
干预措施: OJR520 (Drug)
Part A: OJR520 dose A3
Participants will receive OJR520 dose level A3.
干预措施: OJR520 (Drug)
Part C: OJR520 dose C1
Participants will receive OJR520 dose level C1.
干预措施: OJR520 (Drug)
Part C: OJR520 dose C3
Participants will receive OJR520 dose level C3.
干预措施: OJR520 (Drug)
Part B: OJR520 dose B4
Participants will receive OJR520 dose level B4.
干预措施: OJR520 (Drug)
Part B: OJR520 dose B1
Participants will receive OJR520 dose level B1.
干预措施: OJR520 (Drug)
Part B: OJR520 dose B2
Participants will receive OJR520 dose level B2.
干预措施: OJR520 (Drug)
Part B: OJR520 dose B3
Participants will receive OJR520 dose level B3.
干预措施: OJR520 (Drug)
Part C: OJR520 dose C4
Participants will receive OJR520 dose level C4.
干预措施: OJR520 (Drug)
Part A: Placebo
Participants will receive the matching placebo.
干预措施: Placebo (Other)
Part B: Placebo
Participants will receive the matching placebo.
干预措施: Placebo (Other)
Part C: Placebo
Participants will receive the matching placebo.
干预措施: Placebo (Other)
Part C: OJR520 dose C2
Participants will receive OJR520 dose level C2.
干预措施: OJR520 (Drug)
结局指标
主要结局
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
时间窗: From Day 1 (Part A) until Day 71 (Part C)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
次要结局
- Maximum Observed Blood Concentrations (Cmax)(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Time to reach maximum plasma concentration (Tmax)(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Area under the plasma concentration-time curve (AUC[0-inf])(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Terminal elimination half-life (T1/2)(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Apparent volume of distribution during terminal elimination phase (Vz/F)(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Area under plasma concentration-time curve (AUClast)(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Apparent plasma clearance (CL/F)(From pre-dose Day 1 (Part A) until Day 71 (Part C))
- Drug accumulation ratio (Racc)(Part C: From pre-dose Day 1 until Day 71)
- Area under plasma concentration-time curve (AUCtau)(Part C: From pre-dose Day 1 until Day 71)