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

NCT05905068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-10

No results posted yet for this study

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)

Conditions

  • To Reduce the LDL-C Level in Hypercholesteremia Adult Patients
  • Combination for Subgroup High LDL-c Patients With Other Comorbidities

Interventions

DRUG

RN0191 INJECTION

a sterile solution in each bottle for subcutaneous (SC) injection

Sponsors & Collaborators

  • Ikaria Bioscience Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Kristi McLendon, MD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2024-02-24
Completion
2024-05-14

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05905068 on ClinicalTrials.gov