RN0361 for High Triglycerides

Recruiting at 8 trial locations

Overseen By Amy J zhu

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ikaria Bioscience Pty Ltd

Must not be taking: Alcohol, Drugs of abuse

Disqualifiers: Uncontrolled disease, Pancreatitis, Hypertension, Diabetes, Heart failure, others

Compensation: Varies

Number of Visits: Unknown

108 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults who are healthy or have high triglycerides, with specific blood fat levels. Participants must agree to study procedures and use effective contraception. They cannot donate sperm or eggs during the study.

Inclusion Criteria

I am not pregnant or breastfeeding and use effective birth control. Or, I ensure the use of contraception during the study.

I will not donate sperm or eggs during the study.

I am willing to sign a consent form for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive single ascending doses of RN0361 or placebo to evaluate safety, tolerability, and pharmacokinetics

Up to 12 weeks

Multiple visits for dosing and monitoring

Phase 2 Treatment

Participants receive a single dose of RN0361 or placebo to evaluate pharmacodynamic effects and immunogenicity

Up to 26 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RN0361

Trial Overview The trial tests RN0361's safety and effects on the body in healthy adults and those with high triglycerides. It involves a single dose of RN0361 to see how it's tolerated and how it affects the body's functions.

Participant Groups

Group I: RN0361 Experimental Treatment 1 Intervention

subcutaneous injections

Group II: Placebo Placebo Group 1 Intervention

calculated volume to match active treatment

Who Is Running the Clinical Trial?

Ikaria Bioscience Pty Ltd

Lead Sponsor

Trials

3

Recruited

120+