NCT07838220招募中1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of IBI3016 in Japanese Participants With Mild to Moderate Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female participants aged 18-75 years (inclusive) at the time of informed consent;
- •2. Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin;
- •3. Office mean sitting SBP≥ 140 mmHg and < 170 mmHg at screening
排除标准
- •1. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea;
- •2. History of orthostatic hypotension
- •3. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor
- •4. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening;
- •5. Presence of serious active and uncontrolled physical conditions or medical history, which may be in a dangerous state during the use of the study drug, or interfere with the interpretation of efficacy and safety data of this study, as judged by the investigator prior to randomization
研究组 & 干预措施
IBI3016 Dose1
Experimental
single doses of IBI3016 administered by subcutaneous injection
干预措施: IBI3016 Dose 1 (Drug)
IBI3016 Dose 2
Experimental
single doses of IBI3016 administered by subcutaneous injection
干预措施: IBI3016 Dose 2 (Drug)
IBI3016 Dose4
Experimental
single doses of IBI3016 administered by subcutaneous injection
干预措施: IBI3016 Dose 4 (Drug)
Placebo
Placebo Comparator
single doses of Placebo administered by subcutaneous injection
干预措施: Placebo (Drug)
IBI3016 Dose3
Experimental
single doses of IBI3016 administered by subcutaneous injection
干预措施: IBI3016 Dose 3 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Through 24 weeks, up to approximately 12 months
次要结局
- Urine PK parameter: drug accumulation(Predose, Day 1, and up to 48 hours postdose)
- Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016(Predose, early post-dose and up to 48 hours postdose)
- Plasma PK: Area Under the Concentration Versus Time Curve (AUC) of IBI3016(Predose, Day 1, and up to 48 hours postdose)
- Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessed by OBP and ABPM(Baseline, Month 3 and Month 6)
- Change from baseline in serum angiotensinogen (AGT) concentration(Through 24 weeks, up to approximately 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Evaluating Safety ,Tolerability, Pharmacokinetic,Efficacy of WJ01024 or WJ01024 Combined With Ruxolitinib in Patients With MyelofibrosisMF With SplenomegalyNCT07802405Henan Cancer Hospital20
尚未招募
1 期
GKL-006Allo Injection in Patients With Advanced Solid TumorsSolid Tumor MalignanciesNCT07704515Beijing Gene Key Life Technology Co., Ltd27
招募中
1 期
A Clinical Study of HRS-7156 in Healthy ParticipantsHeart FailureNCT07601087Shandong Suncadia Medicine Co., Ltd.66
进行中（未招募）
1 期
Study of IBI3016 in People With Mild or Moderate Hypertension PatientsHypertensionNCT07556796Innovent Biologics (Suzhou) Co. Ltd.30
尚未招募
1 期
Phase I Clinical Study of LNF2105 in Patients With Advanced Solid TumorsPatients With Advanced Solid TumorsNCT07661797Shandong New Time Pharmaceutical Co., LTD294