Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Description

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.

Conditions

Hypertriglyceridemia, Familial Chylomicronemia Syndrome

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Study Overview

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Study Details

Study overview

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.

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

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Condition
Hypertriglyceridemia
Intervention / Treatment

-

Contacts and Locations

Lilburn

Lifeline Primary Care/Avacare, Lilburn, Georgia, United States, 30047

Versailles

Versailles Family Medicine / Avacare, Versailles, Kentucky, United States, 40383

Dilworth

Axis Clinicals USA, Dilworth, Minnesota, United States, 56529

Webster

Tranquil, Webster, Texas, United States, 77598

Pleasant View

Ogden Clinic, Mountain View / Avacare, Pleasant View, Utah, United States, 84404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \> 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
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Ikaria Bioscience Pty Ltd,

Study Record Dates

2026-12-30