RECRUITING

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-30
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06471543

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing to provide written informed consent before any study-specific procedures.
  2. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol.
  3. * Fasting serum triglyceride levels \> 80 mg/dL and fasting LDL-C ≥70 mg/dL at screening
  4. * 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.
  5. * Participants must avoid sperm or egg donation during the study
  1. * History or presence of any serious or uncontrolled disease
  2. * clinically significant health concerns
  3. * Recent vaccination with live vaccines, except for influenza, or plans to receive such during the study.
  4. * Positive tests for alcohol or drugs of abuse at screening.
  5. * History of multiple drug allergies or allergic reactions to specific components used in the study.

Contacts and Locations

Study Contact

Esther J JIANG
CONTACT
13916015172
esther.jiang@ronatherapeutics.com

Study Locations (Sites)

Lifeline Primary Care/Avacare
Lilburn, Georgia, 30047
United States
Versailles Family Medicine / Avacare
Versailles, Kentucky, 40383
United States
Axis Clinicals USA
Dilworth, Minnesota, 56529
United States
Tranquil
Webster, Texas, 77598
United States
Ogden Clinic, Mountain View / Avacare
Pleasant View, Utah, 84404
United States

Collaborators and Investigators

Sponsor: Ikaria Bioscience Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertriglyceridemia
  • Familial Chylomicronemia Syndrome