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Recruiting Phase 1 NCT07347678

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
Locations 1
Australia (1)
Q-Pharm Pty Ltd.
Brisbane , Queensland
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
12.03.2026
Completion date
01.07.2027
Registry ID
NCT07347678
Source
anzctr
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