NCT07347678 Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
| NCT ID | NCT07347678 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ikaria Bioscience Pty Ltd |
| Condition | High Cholesterol |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-12 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-03-12 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07347678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying High Cholesterol. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07347678 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07347678 currently recruiting?
Yes, NCT07347678 is actively recruiting participants. Contact the research team at dan.xiang@ronatherapeutics.com for enrollment information.
Where is the NCT07347678 trial being conducted?
This trial is being conducted at Brisbane, Australia, Melbourne, Australia.
Who is sponsoring the NCT07347678 clinical trial?
NCT07347678 is sponsored by Ikaria Bioscience Pty Ltd. The trial plans to enroll 60 participants.