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Clinical Trials in Australia / NCT07347678
Recruiting Phase 1

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

NCT07347678 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2026-03-12
Last updated
2026-04-03

Condition(s) studied

High Cholesterol

Investigational drug(s) / intervention(s)

RN5681Placebo control

RN5681: Investigational Product

Placebo control: 0.9% normal saline SC injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Q-Pharm Pty Ltd. Brisbane Queensland Recruiting
Nucleus Network Pty Ltd. Melbourne Victoria Recruiting

More Ikaria Bioscience Pty Ltd trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347678 on ClinicalTrials.gov ↗ ← All trials in Australia