Actively Recruiting
A First-in-Human Study to Assess the Safety and Tolerability of Single and Multiple Doses of SNS851 in Healthy Participants
Led by Oneness Biotech Co., Ltd. · Updated on 2026-03-23
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes the drug SNS851 when given under the skin to healthy adults. This Phase I, randomized, double-blind study focuses on healthy participants aged 18 to 55 to understand potential side effects and drug behavior before further testing. The trial is sponsored by Oneness Biotech Co., Ltd. and targets metabolic diseases. Participants will be randomly assigned to receive either low to high single or multiple doses of SNS851 or placebo (normal saline). The study includes several dosing groups to assess different amounts and schedules of the investigational drug compared to placebo. Both treatments are administered subcutaneously, and participants remain unaware of which group they are in. Throughout the study, participants will undergo regular monitoring for any adverse events, including serious or treatment-related side effects, for up to 3 months after the last dose (or 6 months for certain dosing groups). Safety assessments include physical exams, laboratory tests, and adherence to contraceptive methods if applicable. The total participation duration varies depending on dosing schedule and follow-up requirements.
CONDITIONS
Brief 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 study visits and procedures
- Healthy male or female aged 18 to 55 years inclusive 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 prior to dosing and no plans to change during study
- No acute illness within 4 weeks before check-in
- Willing to refrain from caffeine and xanthene products for 12 hours before visits and during confinement
- If of reproductive potential, willing to use effective contraception from consent through 90 days after last dose
You will not qualify if you...
- Weight loss over 10% within 3 months prior to screening
- Any clinically significant abnormal safety lab results
- Known chronic liver disease
- History or existing kidney disease
- History of cardiac arrhythmias or significant heart events in past 6 months
- QTcF interval duration over 450 msec (male) or 470 msec (female) at screening or Day 0
- Significant lung or respiratory diseases or COVID-19 sequelae
- Use of investigational agents within 30 days or 5 half-lives before dosing
- Prior long-duration RNA-based therapies within 12 months
- Use of prescription or over-the-counter medications within 14 or 7 days before dosing (with some exceptions)
- Recent vaccinations within 14 days before dosing
- Use of anabolic steroids or systemic glucocorticosteroids within 3 months prior
- Substance dependence or positive drug/alcohol tests at screening
- Smoking or use of nicotine products indicated by urinary cotinine
- Recent illness, surgery, or trauma within 4 weeks before dosing
- History or likelihood of injection site reactions or aversion to subcutaneous injections
- Blood donation within 3 months prior to dosing
- Skin conditions at injection sites that may interfere with assessments
- Any uncontrolled or serious disease or condition affecting participation or data
- Any other condition or therapy making participant unsuitable
- Hypersensitivity to oligonucleotide therapeutics or injection-site reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on dosing schedule (single or multiple doses)
Participants receive single or multiple doses of the investigational drug SNS851 or placebo to assess safety and tolerability.
Visits occur according to dosing schedule
Duration - Up to 3 months after last dose (6 months for last cohort)
Participants are monitored for safety including adverse events for up to 3 months after the last dose (6 months for the last multiple ascending dose cohort).
Regular follow-up visits during the monitoring period
Trial Site Locations
Total: 1 location
1
Veritus Research
Melbourne, Australia
Actively Recruiting
Research Team
P
Pei-Jin Ho
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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