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)
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681 — 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
in POC cohort, To assess the metabolic markers of efficacy — From enrollment to the end of treatment at Day 180 Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
Trial sites (2)
Facility
City
Region
Status
Q-Pharm Pty Ltd.
Brisbane
Queensland
Recruiting
Nucleus Network Pty Ltd.
Melbourne
Victoria
Recruiting
More Ikaria Bioscience Pty Ltd trials in Australia
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.