Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07417124

Assess the Safety and Tolerability of SNS851 in Healthy Participants

Led by Oneness Biotech Co., Ltd. · Updated on 2026-03-23

52

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase I, randomized, double-blind study designed to evaluate the safety, tolerability and pharmacokinetics of subcutaneous administration of SNS851 in healthy participants.

CONDITIONS

Official Title

Assess the Safety and Tolerability of SNS851 in Healthy Participants

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent and willing to complete all visits and procedures
  • Healthy male or female aged 18 to 55 years at screening
  • Body mass index (BMI) between 18 and 32 kg/m2 at screening
  • Negative tests for HIV, hepatitis B, and hepatitis C at screening
  • No major changes in diet, alcohol, or physical activity within 4 weeks before dosing and no plans to change during study
  • No acute illness within 4 weeks before check-in
  • Willing to avoid caffeine and xanthene products for 12 hours before visits and during confinement
  • Use of highly effective contraception from consent through 90 days after last dose for participants of reproductive potential
Not Eligible

You will not qualify if you...

  • Weight loss of more than 10% within 3 months prior to screening
  • Clinically significant abnormal lab results as judged by the investigator
  • Evidence of chronic liver disease
  • History or presence of renal disease
  • History of cardiac arrhythmias, sudden cardiac death, syncope, significant cardiovascular events, uncontrolled hypertension, or orthostatic hypotension within 6 months before screening
  • QTcF interval >450 msec for males or >470 msec for females at screening or Day 0
  • Clinically significant pulmonary or respiratory disease or COVID-19 sequelae increasing study risk
  • Participation in investigational drug/device study or use of investigational agents within 30 days or 5 half-lives before dosing
  • History of long-duration RNA-based therapies within 12 months before Day 1
  • Use of prescription or over-the-counter medications, vitamins, or supplements within 14 or 7 days before first dose (exceptions apply)
  • Vaccination within 14 days before first dose
  • Use of anabolic steroids or systemic glucocorticosteroids within 3 months before screening
  • History of substance dependence or positive drug/alcohol tests at screening
  • Smoking or nicotine use as evidenced by urinary cotinine or history
  • Recent illness, medical procedures, or trauma within 4 weeks of first dose
  • History of or aversion to subcutaneous injections causing site reactions
  • Blood donation within 3 months before first dose
  • Skin conditions at injection sites that could interfere with safety assessment
  • Uncontrolled or serious medical or surgical conditions interfering with participation
  • Any condition or therapy making participant unsuitable or likely noncompliant
  • History of hypersensitivity to oligonucleotide therapeutics or injection-site reactions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Veritus Research

Melbourne, Australia

Actively Recruiting

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Research Team

P

Pei-Jin Ho

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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