Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
Recruiting · NCT07347678 · Interventional (participants receive a specific treatment) · Lead sponsor: Ikaria Bioscience Pty Ltd
View the official record on ClinicalTrials.gov →Interventions studied
Placebo controlRN5681
What this trial is about
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 take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Q-Pharm Pty Ltd. - Brisbane, Queensland, Australia
- Nucleus Network Pty Ltd. - Melbourne, Victoria, Australia