NCT07223658招募中1 期
Phase 1/2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 17
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to follow diet counseling as per Investigator judgment based on local standard of care
- •Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening
- •Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later
排除标准
- •Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA
- •Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy
- •Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)
- •Uncontrolled hypertension
- •History of bleeding diathesis or coagulopathy
- •Current diagnosis of nephrotic syndrome
- •Note: Additional inclusion/exclusion criteria may apply per protocol.
研究组 & 干预措施
ARO-DIMERPA
Experimental
ARO-DIMERPA in single or multiple ascending doses
干预措施: ARO-DIMERPA (Drug)
Placebo
Placebo Comparator
Placebo (normal saline, 0.9%) in single or multiple matching doses
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Week 36
次要结局
- PK of ARO-DIMERPA: Time to Maximum Plasma Concentration (Tmax)(Through 24 hours postdose)
- PK of ARO-DIMERPA: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)(Through 24 hours postdose)
- Percent Change from Baseline in Fasting LDL-C(Baseline to Week 36)
- Percent Change from Baseline in Fasting TGs(Baseline to Week 36)
- Percent Change from Baseline in Serum apoC-III(Baseline to Week 36)
- Percent Change from Baseline in Serum PCSK9(Baseline to Week 36)
- PK of ARO-DIMERPA: Maximum Observed Plasma Concentration (Cmax)(Through 24 hours postdose)
- PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)(Through 24 hours postdose)
- PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)(Through 24 hours postdose)
- PK of ARO-DIMERPA: Apparent Terminal Elimination Half-life (t1/2)(Through 24 hours postdose)
- PK of ARO-DIMERPA: Apparent Systemic Clearance (CL/F)(Through 24 hours postdose)
- PK of ARO-DIMERPA: Apparent Terminal-phase Volume of Distribution (Vz/F)(Through 24 hours postdose)
- PK of ARODIMERPA: Recovery of Unchanged Drug (Ae) in Urine From Time Zero to 24 Hours Postdose(Through 24 hours postdose)
- PK of ARO-DIMERPA: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose(Through 24 hours postdose)
- PK of ARO-DIMERPA: Renal Clearance (CLR)(Through 24 hours postdose)
研究者
研究点 (17)
Loading locations...
相似试验
招募中
2 期
A Study of ORX750 in Subjects with Narcolepsy and Idiopathic Hypersomnia2024-518929-15-00Centessa Pharmaceuticals UK Limited96
已完成
1 期
Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes MellitusOverweight or ObesityType2 Diabetes MellitusNCT05762471Gasherbrum Bio, Inc142
已完成
早期 1 期
A Study of SYNT001 in Healthy VolunteersHealthyNCT03643627Syntimmune, Inc.31
已完成
2 期
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to TrikaftaNCT07108153Sionna Therapeutics Inc.15
已完成
2 期
Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase InhibitorArthritis, RheumatoidNCT05198310Kiniksa Pharmaceuticals, Ltd.145