High CholesterolPhase 1NCT07347678
Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
A Phase 1 study testing RN5681 in people with High Cholesterol, run by Ikaria Bioscience Pty Ltd at 2 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Cholesterol
- What is being tested?
- RN5681
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- 12 Mar 2026to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Q-Pharm Pty Ltd.
Brisbane, Queensland, 4006
Emma Trowbridge, (07) 3707 2720, e.trowbridge@nucleusnetwork.com.au
Emma Trowbridge
- Recruiting
Nucleus Network Pty Ltd.
Melbourne, Victoria, 3004
Philip Ryan, MD, (03) 8593 9801, p.ryan@nucleusnetwork.com.au
Philip Ryan, MD
About this study
Official title: A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
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
- High Cholesterol
- Being tested
- RN5681, Placebo control
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN5681Drug
Investigational Product
Placebo controlDrug
0.9% normal saline SC injection
| Study group | Role | What they receive |
|---|---|---|
| RN5681 | Experimental | Drug: RN5681 Investigational product subcutaneous injections Receives: Drug: RN5681 |
| Placebo | Placebo comparator | Drug: Placebo control 0.9% normal saline subcutaneous injection Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of treatment at Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start12 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ikaria Bioscience Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Rona Therapeutics Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347678
- Sponsor's protocol ID
- RN5681-101
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07347678
- Acronym / sponsor ID
- RN5681-101
- Conditions
- High Cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ikaria Bioscience Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Rona Therapeutics Co., Ltd.
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RN5681 | Experimental | Drug: RN5681Drug: RN5681 Investigational product subcutaneous injections |
| Placebo | Placebo comparator | Drug: Placebo controlDrug: Placebo control 0.9% normal saline subcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RN5681Investigational Product | Drug | RN5681 |
| Placebo control0.9% normal saline SC injection | Drug | Placebo |
Primary outcome
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
Time frame: From the enrollment to the end of treatment at Day180
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
in POC cohort, To assess the metabolic markers of efficacy
Time frame: From enrollment to the end of treatment at Day 180
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RN5681 in people with High Cholesterol, run by Ikaria Bioscience Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Xiang (+86 18516063568, dan.xiang@ronatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681 (time frame: From the enrollment to the end of treatment at Day180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.