RecruitingPhase 1NCT07347678
Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
Sponsor
Ikaria Bioscience Pty Ltd
Enrollment
60 participants
Start Date
Mar 12, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
DRUGRN5681
Investigational Product
DRUGPlacebo control
0.9% normal saline SC injection
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07347678