The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
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
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
Parallel
RN5681
DrugInvestigational Product
Placebo control
Drug0.9% normal saline SC injection
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
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
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
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Ikaria Bioscience Pty Ltd
Lead sponsor
Shanghai Rona Therapeutics Co., Ltd.
Collaborator
