Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Veritus Research
Melbourne, Australia
Actively Recruiting
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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