Study of RN0361 in Adult Subjects

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About the study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single and multiple doses of RN0361 in Adult subjects.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion 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

EXCLUSION CRITERIA

Exclusion Criteria:


  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.

Note: Additional inclusion/exclusion ceiteria may apply, per protocol.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 13916015172Email iconEmail Study Center

Study’s details


Contition
Hypertriglyceridemia,Familial Chylomicronemia
Age
18 - 60
Phase
PHASE1
Participants needed
60
Est. Completion Date
Jun 30, 2026
Treatment type
INTERVENTIONAL

Sponsor
Ikaria Bioscience Pty Ltd
ClinicalTrials.gov identifier
NCT06471543
Study number
RN0361-101

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