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临床试验/NCT06471543
NCT06471543进行中（未招募）1 期

A Phase 1, Randomized, Placebo-controlled, Single Ascending Dose and Phase 2 Randomized, Placebo Controlled, Parallel-Group, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects, and Immunogenicity of RN0361 in Adult Healthy Subjects and Hypertriglyceridemic Subjects

Ikaria Bioscience Pty Ltd10 个研究点 分布在 2 个国家目标入组 108 人开始时间: 2024年9月30日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
108
试验地点
10
主要终点
Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.

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 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 before any study-specific procedures.
  • •Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol.
  • •Fasting serum triglyceride levels > 80 mg/dL and fasting LDL-C ≥70 mg/dL at screening
  • •Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential.
  • •Participants must avoid sperm or egg donation during the study

排除标准

  • •History or presence of any serious or uncontrolled disease
  • •clinically significant health concerns
  • •Recent vaccination with live vaccines, except for influenza, or plans to receive such during the study.
  • •Positive tests for alcohol or drugs of abuse at screening.
  • •History of multiple drug allergies or allergic reactions to specific components used in the study.
  • •Inclusion Criteria:
  • •Willing to provide written informed consent before any study-specific procedures.
  • •Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol.
  • •Fasting serum triglyceride levels ≥ 300 mg/dL at screening
  • •Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential.
  • •Exclusion Criteria:
  • •History or presence of any serious or uncontrolled disease
  • •Active pancreatitis within 12 weeks prior to Day 1
  • •Uncontrolled hypertension (sitting blood pressure) >160/100 mm Hg
  • •Uncontrolled diabetes
  • •Symptomatic heart failure (NYHA II-IV)
  • •Positive serologic test of HBV, HCV, or HIV
  • •Alcohol or drugs abuse
  • •History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
  • •History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc)
  • •History of malignancy within the last 2 years prior to the date of consent
  • •Note: Additional inclusion/exclusion ceiteria may apply, per protocol.

研究组 & 干预措施

RN0361

Experimental

subcutaneous injections

干预措施: RN0361 (Drug)

Placebo

Placebo Comparator

calculated volume to match active treatment

干预措施: RN0361 (Drug)

结局指标

主要结局

Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects.

时间窗: Up to Day85

Phase 1

Absolute and percent change from baseline in APOC3 and fasting triglycerides (TG) in subjects with HTG

时间窗: Up to Day183

Phase 2

次要结局

  • Plasma pharmacokinetics (PK) parameters (Cmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Plasma pharmacokinetics (PK) parameters (Tmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Plasma pharmacokinetics (PK) parameters (AUC 0-24) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Plasma pharmacokinetics (PK) parameters (t1/2) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Plasma pharmacokinetics (PK) parameters (AUC0-inf) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Plasma pharmacokinetics (PK) parameters (Vz/F) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Plasma pharmacokinetics (PK) parameters (λz) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to 48 hours post-dose)
  • Urine pharmacokinetics (PK) parameters (CLR) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to Day 85)
  • Urine pharmacokinetics (PK) parameters (Aet) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to Day 85)
  • Urine pharmacokinetics (PK) parameters (Aeu) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to Day 85)
  • Urine pharmacokinetics (PK) parameters (FE) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects.(Up to Day 85)
  • Absolute and percent change from baseline in APOC3 in adult healthy subjects.(Up to Day 85)
  • Absolute and percent change from baseline in TG in adult healthy subjects.(Up to Day 85)
  • Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in subjects with HTG.(Up to Day 183)
  • Absolute and percent change from baseline in remnant cholesterol and VLDL-C in subjects with HTG.(Up to Day 183)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (10)

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