Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers

March 30, 2026 updated by: Ikaria Bioscience Pty Ltd

A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects

Study Overview

Status

Recruiting

Conditions

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 Contact Backup

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Nucleus Network Pty Ltd.
        • Contact:
        • Principal Investigator:
          • Philip Ryan, MD

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body mass index (BMI) 18 to 35 kg/m2
  • Fasting LDL-C ≥70 mg/dL (1.81 mmol/L) (all SAD cohorts); fasting LDL-C ≥100 mg/dL (2.59 mmol/L) (POC cohort only)
  • Lp(a) at Screening: SAD cohort: ≥25 nmol/L POC cohort: ≥100 nmol/L
  • Fasting triglycerides <400 mg/dL (4.51 mmol/L) at Screening
  • No clinically significant abnormalities of hepatic or renal function

Exclusion Criteria:

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal at screening
  • Hemoglobin A1c (HbA1c) ≥6.5% at screening
  • Current regular smoker (defined as >2 cigarettes/day or >10 cigarettes/week) within 3 months prior to screening
  • Use of any siRNA, antisense oligonucleotide (ASO), cell and gene therapy, or clustered regularly interspaced short palindromic repeats (CRISPR) agent in the prior 12 months
  • Received any prescription lipid-lowering medication, including but not limited to statins, ezetimibe, and PCSK9 inhibitors to alter serum lipids within 30 days before screening

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: RN5681
Drug: RN5681 Investigational product subcutaneous injections
Drug: RN5681
Investigational Product
Placebo Comparator: Placebo
Drug: Placebo control 0.9% normal saline subcutaneous injection
Drug: Placebo control
0.9% normal saline SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
Time Frame: From the enrollment to the end of treatment at Day180
Incidence, severity, and causal relationship of adverse events (AEs) as reported by the Investigator, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0
From the enrollment to the end of treatment at Day180
in POC cohort, To assess the metabolic markers of efficacy
Time Frame: From enrollment to the end of treatment at Day 180
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
From enrollment to the end of treatment at Day 180

Collaborators and Investigators

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

Sponsor

Ikaria Bioscience Pty Ltd

Collaborators

Shanghai Rona Therapeutics Co., 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 Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN5681-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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