Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
Phase 1 – testing safety in a small group of people
Conditions:
High Cholesterol
Sponsor: Ikaria Bioscience Pty Ltd
trial.available_in:
БГ
Overview
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
Who can participate
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