Overview

Adult Subjects With Elevated Low-Density Lipoprotein-Cholesterol to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects

Status:
Not yet recruiting
Trial end date:
2024-07-27
Target enrollment:
Participant gender:
Summary
Objectives: The primary and secondary objectives of the study are presented below. Exploratory objectives are presented in the body of the protocol. Primary: • To determine the safety and tolerability of RN0191 administered as escalating single subcutaneously (SC) doses in adult subjects with elevated low-density lipoprotein-cholesterol Secondary: - To evaluate the single-dose pharmacokinetics (PK) of RN0191 in adult subjects with elevated low-density lipoprotein-cholesterol - To evaluate the pharmacodynamic (PD) effect of RN0191 on serum levels of low-density lipoprotein-cholesterol (LDL-C) - To evaluate the PD effect of RN0191 on plasma levels of proprotein convertase subtilisin/kexin type 9 (PCSK9)
Phase:
Phase 1
Details
Lead Sponsor:
Ikaria Bioscience Pty Ltd