Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Launched by IKARIA BIOSCIENCE PTY LTD · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RN0361 to see how safe it is, how well it works, and how the body processes it in adults with high levels of triglycerides (a type of fat in the blood) and a specific genetic condition called Familial Chylomicronemia. The research is currently not recruiting participants, but when it starts, it will involve adults aged 18 to 75. To join the study, participants must have high triglyceride levels and agree to follow the study's rules, including using effective birth control if they are able to have children.

Participants in this trial can expect to receive either single or multiple doses of the medication, and they will be closely monitored for any side effects or changes in their health during the study. It’s important to note that people with serious health issues or certain allergies may not be eligible to participate. The study also requires participants to avoid donating sperm or eggs while they are involved. Overall, this trial aims to gather important information that could help improve treatments for individuals with high triglyceride levels.

Gender

ALL

Eligibility criteria

• • Phase I：
• 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 \> 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
• Exclusion Criteria:
• • 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.
• Phase II:
• 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.