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Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers Phase 1 60 Single Dose

Not yet recruiting
Clinical Trial NCT07347678 is designed to study Treatment for High Cholesterol. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 31 March 2026 until the study accrues 60 participants. Led by Ikaria Bioscience Pty Ltd, this study is expected to complete by 1 July 2027. The latest data from ClinicalTrials.gov was last updated on 16 January 2026.
Brief 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
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

Conditions
High Cholesterol
Other Study IDs
  • RN5681-101
NCT ID Number
NCT07347678
Start Date (Actual)
2026-03-31
Last Update Posted
2026-01-16
Completion Date (Estimated)
2027-07
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRN5681
Drug: RN5681 Investigational product subcutaneous injections
RN5681
Investigational Product
Placebo ComparatorPlacebo
Drug: Placebo control 0.9% normal saline subcutaneous injection
Placebo control
0.9% normal saline SC injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
From enrollment to the end of treatment at Day 180
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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
Ikaria Bioscience Pty Ltd logoIkaria Bioscience Pty Ltd
Shanghai Rona Therapeutics Co., Ltd. logoShanghai Rona Therapeutics Co., Ltd.
Study Central Contact
Contact: Dan Xiang, +86 18516063568, [email protected]
2 Study Locations in 1 Countries

Queensland

Q-Pharm Pty Ltd., Brisbane, Queensland, 4006, Australia
Emma Trowbridge, Contact, (07) 3707 2720, [email protected]
Emma Trowbridge, Principal Investigator

Victoria

Nucleus Network Pty Ltd., Melbourne, Victoria, 3004, Australia
Philip Ryan, MD, Contact, (03) 8593 9801, [email protected]
Philip Ryan, MD, Principal Investigator