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

A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07347678

Enrollment

Registered

2026-01-16

Start date

2026-03-12

Completion date

2027-07-01

Last updated

2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Cholesterol

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

Interventions

DRUGRN5681

Investigational Product

DRUGPlacebo control

0.9% normal saline SC injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681	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	From enrollment to the end of treatment at Day 180	Percent change from Baseline in serum LDL-C and Lp(a) at Day 180

Countries

Australia

Contacts

CONTACTDan Xiang

dan.xiang@ronatherapeutics.com+86 18516063568

CONTACTJie Zeng

jie.zeng@ronatherapeutics.comjie.zeng@ronatherapeutics.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026