RN5681 dosing and safety in healthy adults with elevated LDL and Lp(a)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1a, randomized, placebo-controlled single ascending dose study gives one dose of RN5681 to healthy adult volunteers who meet specified LDL-C and Lp(a) thresholds to measure safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The protocol includes multiple single ascending dose (SAD) cohorts and a proof-of-concept (POC) cohort with higher required Lp(a) levels. Participants receive RN5681 or placebo at clinical research units in Brisbane and Melbourne with serial blood sampling, safety monitoring, and scheduled follow-up visits. People using prescription lipid-lowering medications or with significant liver, kidney, or metabolic abnormalities are excluded to focus on safety and early pharmacology signals.

Why it matters

Who can join: the full rules

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

Where it's running

• Q-Pharm Pty Ltd.
  Brisbane, Queensland, Australia Recruiting
• Nucleus Network Pty Ltd.
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Dan Xiang
• Email: dan.xiang@ronatherapeutics.com
• Phone: +86 18516063568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.