Actively Recruiting
Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
Led by Ikaria Bioscience Pty Ltd · Updated on 2026-04-03
60
Participants Needed
2
Research Sites
68 weeks
Total Duration
On this page
Sponsors
I
Ikaria Bioscience Pty Ltd
Lead Sponsor
S
Shanghai Rona Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
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
CONDITIONS
Official Title
Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) 18 to 35 kg/m2
- Fasting LDL-C 70 mg/dL (1.81 mmol/L) for SAD cohorts; 100 mg/dL (2.59 mmol/L) for POC cohort
- Lp(a) 25 nmol/L for SAD cohort; 100 nmol/L for POC cohort
- Fasting triglycerides less than 400 mg/dL (4.51 mmol/L) at screening
- No clinically significant abnormalities of liver or kidney function
You will not qualify if you...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal
- Hemoglobin A1c (HbA1c) greater than 6.5% at screening
- Current regular smoker (more than 2 cigarettes/day or more than 10 cigarettes/week) within 3 months prior to screening
- Use of any siRNA, antisense oligonucleotide (ASO), cell and gene therapy, or CRISPR agent in the past 12 months
- Use of any prescription lipid-lowering medication within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia, 4006
Actively Recruiting
2
Nucleus Network Pty Ltd.
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
D
Dan Xiang
CONTACT
J
Jie Zeng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here