Study of RN0361 in Adult Subjects

June 18, 2024 updated by: Ikaria Bioscience Pty Ltd

A Phase 1, Randomized, Single-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Immunogenicity of RN0361 in Adult Subjects With Elevated Triglycerides

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RN0361
subcutaneous injections
solution
Placebo Comparator: Placebo
calculated volume to match active treatment
solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides
Time Frame: Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Incidence and frequency of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361
Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides
Time Frame: Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Number of Participants with clinically significant changes in clinical laboratory safety tests (hematology, biochemistry, coagulation, and urinalysis) related to treatment of RN0361
Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides
Time Frame: Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Number of Participants with clinically significant changes in vital signs (oral body temperature, blood pressure, heart rate, and respiration rate)
Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides
Time Frame: Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Number of Participants with clinically significant changes in 12-lead electrocardiograms (ECGs)
Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides
Time Frame: Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Number of Participants with clinically significant changes in physical examinations
Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides
Time Frame: Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.
Incidence and frequency of injection site reactions (ISRs)
Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Time to reach maximum plasma concentration (tmax) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Area under the plasma concentration-time curve from time zero to 24h post-dose (AUC0-24) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Terminal elimination half-life (t1/2) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Elimination rate constant (λz) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Apparent volume of distribution (Vz/F) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Renal clearance (CLR) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Amount of drug excreted in the urine over the collection interval t (Aet) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Cumulative amount of drug excreted in urine at the end of each interval (Aeu) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Fraction of dose excreted in the urine over the collection interval (FE) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Cumulative fraction of dose excreted in the urine over collection intervals (FEu) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1
Time Frame: Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.
Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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