A Phase 1 interventional study of RN5681 and Placebo control in High Cholesterol, sponsored by Ikaria Bioscience Pty Ltd. Recruiting at 2 sites in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Ikaria Bioscience Pty Ltd · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 60 is below the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Ikaria Bioscience Pty Ltd is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: RN5681 Investigational product subcutaneous injections
Drug: RN5681
Drug: Placebo control 0.9% normal saline subcutaneous injection
Drug: Placebo control
Investigational Product
0.9% normal saline SC injection
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
Incidence, severity, and causal relationship of adverse events (AEs) as reported by the Investigator, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0
Time frame: From the enrollment to the end of treatment at Day180
in POC cohort, To assess the metabolic markers of efficacy
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
Time frame: From enrollment to the end of treatment at Day 180
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
Of 41 industry-sponsored phase 1 interventional studies under Hypercholesterolemia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's planned 11 months is above that.
Counting every sponsor, half of 46 studies reached it within 7 months; a quarter within 2 and three quarters within 10.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ikaria Bioscience Pty Ltd