NCT06209177已完成1 期
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ARO-CFB in Adult Healthy Volunteers and Adult Patients With Complement-Mediated Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.
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)
盲法说明
Participants are randomized to receive either ARO-CFB or placebo. Participants, care providers, investigator and outcomes assessors are all blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to provide written informed consent and to comply with study requirements
- •Female participants must be non-pregnant/non-lactating
- •Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. IgAN participants must have been vaccinated or willing to undergo vaccination
- •All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae type B
- •Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
- •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 the 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.
- •No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.
排除标准
- •History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
- •History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
- •Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •History of meningococcal infection
- •History of asplenia
- •History of severe aplastic anemia or concurrent severe aplastic anemia
- •Known or suspected hereditary complement deficiency or other primary immunodeficiency syndrome
- •History of diabetes mellitus (Type 1 or Type 2)
- •Uncontrolled hypertension
- •Note: Additional Inclusion/Exclusion criteria may apply per protocol
研究组 & 干预措施
ARO-CFB (Healthy Volunteers)
Experimental
1 or 2 doses of ARO-CFB by subcutaneous (sc) injection
干预措施: ARO-CFB (Drug)
Placebo (Healthy Volunteers)
Experimental
placebo calculated volume to match active treatment by sc injection
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
时间窗: up to Day 169 (End of Study [EOS])
次要结局
- PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)(up to 48 hours post-dose)
- PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)(up to 48 hours post-dose)
- PK of ARO-CFB: Terminal Elimination Half-Life (t1/2)(up to 48 hours post-dose)
- PK of ARO-CFB: Apparent Clearance (CL/F)(up to 48 hours post-dose)
- PK of ARO-CFB: Volume of Distribution (Vz/F)(up to 48 hours post-dose)
- PK of ARO-CFB: Amount of Drug Recovered in Urine Over Zero - 24 Hours Post-dose (Ae)(up to 24 hours post-dose)
- PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe)(up to 24 hours post-dose)
- PK of ARO-CFB: Renal Clearance (CLr)(up to 24 hours post-dose)
- Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)(up to 48 hours postdose)
- PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)(up to 48 hours post-dose)
- PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)(up to 48 hours post-dose)
研究者
研究点 (1)
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