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Recruiting NCT07347678

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

Phase I Interventional High Cholesterol

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RN5681, Placebo control.
Who it may be relevant to
Registry conditions: High Cholesterol. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug RN5681
    Investigational Product
  • Drug Placebo control
    0.9% normal saline SC injection

Primary outcome measures

  • 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]
  • in POC cohort, To assess the metabolic markers of efficacy [Time frame: From enrollment to the end of treatment at Day 180]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Australia · 2 centers
  • Q-Pharm Pty Ltd. — Brisbane
  • Nucleus Network Pty Ltd. — Melbourne

Identifiers

NCT: NCT07347678 · RN5681-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗