Metabolic DiseasePhase 1NCT07417124
Assess the Safety and Tolerability of SNS851 in Study Participants
A Phase 1 study testing SNS851 in people with Metabolic Disease, run by Oneness Biotech Co., Ltd. at 1 site in Australia.
Trial summary
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 and participants with metabolic disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- SNS851
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Apr 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide written informed consent. Willing, committed, and able to return for all clinic visits and complete all protocol specified procedures.
- Healthy male or female, aged between 18 and 55 years (MAD: aged between 18 and 60 years), inclusive at screening.
- Body mass index (BMI) of greater than or equal to 18 kg/m2 and lesser than or equal to 32 kg/m2 at Screening.
- Liver fat measurements above the normal range.
- Negative human immunodeficiency virus, viral hepatitis B and C serology at Screening.
- No major changes in diet, alcohol intake, or physical activity within 4 weeks before dosing and no intention to modify during confinement or follow-up.
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- No acute illness in the 4 weeks prior to check-in, as established by physical examination and medical history.
- Participant is willing to refrain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) for 12 hours before each study visit and while being confined to the study site.
- All participants of reproductive potential must use a highly effective contraceptive method from consent through 90 days after last dose.
Who cannot join
- Weight loss of more than 10% within the last 3 months prior to screening.
- Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee)
- In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease
- Participants with history or pre-existing renal disease
- Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and/or syncope and/or clinically significant cardiovascular event or history of uncontrolled hypertension or orthostatic hypotension within the last 6 months prior to the Screening Visit.
- QTcF interval duration > 450 msec for male or > 470 msec for female at Screening or Day 0.
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- Evidence or history of clinically significant pulmonary and respiratory diseases, including any clinically significant pulmonary disease or sequelae of COVID-19 infection that may increase risk from study participation.
- Use of an investigational agent or device within 30 days or 5 half-lives since last dose of prior investigational product or device of Day 1 drug administration in this trial, whichever is longer prior to dosing or current participation in an investigational study.
- History of having received long-duration RNA-based therapies within 12 months of Day 1.
- Use of any prescription medication or concomitant medications within 14 days prior to the first dose of study drug, or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, iron supplements for participants who have ferritin between 15-30 µg/L at screening, occasional paracetamol (up to a maximum of 2 grams per day).
- Use of any vaccinations within 14 days prior to the first study drug administration.
- Use of anabolic steroids and systemic treatment with glucocorticosteroids within 3 months prior to the Screening Visit.
- History of substance dependence (within the last 12 months) or positive urine drug screen at screening or positive alcohol breath tests at screening.
- Urinary cotinine levels at screening are indicative of smoking or participant has a history of regular use of tobacco- or nicotine-containing products.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- In the opinion of the PI (or designee), has an aversion to, or has history of site reactions to Subcutaneous administrations that would make them unsuitable for inclusion in this trial.
- Has donated blood or blood products within 3 months prior to first dose administration.
- Presence or evidence of recent sunburn, scar tissue, tattoo, open sore or branding that, in the opinion of the PI or medically qualified designee, would interfere with the interpretation of skin adverse reactions at the injection site
- In the opinion of the PI (or designee), has any uncontrolled or serious disease, medical or surgical condition that may interfere with participation or data interpretation.
- Any other condition or prior therapy that in the opinion of the PI (or designee) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
- History of hypersensitivity to oligonucleotide therapeutics or injection-site reactions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A First-in-Human Study to Assess the Safety and Tolerability of Single and Multiple Doses of SNS851
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 and participants with metabolic disease.
- Conditions
- Metabolic Disease
- Being tested
- SNS851, Placebo
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS851Drug
SNS851 is a potent siRNA treatment targeting metabolic diseases.
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| SNS851 | Experimental | Eligible participants will be assigned to receive low-high single or multiple doses of the investigational drug. Receives: Drug: SNS851 |
| Placebo | Placebo comparator | Eligible participants will be assigned to single or multiple doses of the placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Measured: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Incidence of withdrawals due to Adverse Events (AEs)
Measured: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Incidence of Treatment-Related Adverse Events
Measured: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Incidence of Serious Adverse Events (SAEs)
Measured: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417124
- Sponsor's protocol ID
- SNS851CLCT01
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Assess the Safety and Tolerability of Single and Multiple Doses of SNS851
- ClinicalTrials.gov ID
- NCT07417124
- Acronym / sponsor ID
- SNS851CLCT01
- Conditions
- Metabolic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and participants with metabolic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNS851 | Experimental | Drug: SNS851Eligible participants will be assigned to receive low-high single or multiple doses of the investigational drug. |
| Placebo | Placebo comparator | Other: PlaceboEligible participants will be assigned to single or multiple doses of the placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to provide written informed consent. Willing, committed, and able to return for all clinic visits and complete all protocol specified procedures.
- Healthy male or female, aged between 18 and 55 years (MAD: aged between 18 and 60 years), inclusive at screening.
- Body mass index (BMI) of greater than or equal to 18 kg/m2 and lesser than or equal to 32 kg/m2 at Screening.
- Liver fat measurements above the normal range.
- Negative human immunodeficiency virus, viral hepatitis B and C serology at Screening.
Key exclusion criteria (21 listed)
- Weight loss of more than 10% within the last 3 months prior to screening.
- Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee)
- In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease
- Participants with history or pre-existing renal disease
- Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and/or syncope and/or clinically significant cardiovascular event or history of uncontrolled hypertension or orthostatic hypotension within the last 6 months prior to the Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNS851SNS851 is a potent siRNA treatment targeting metabolic diseases. | Drug | SNS851 |
| PlaceboNormal saline | Other | Placebo |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Incidence of withdrawals due to Adverse Events (AEs)
Time frame: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Incidence of Treatment-Related Adverse Events
Time frame: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Incidence of Serious Adverse Events (SAEs)
Time frame: 3 months after last dose (6 months after last dose only for the last MAD cohort)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNS851 in people with Metabolic Disease, run by Oneness Biotech Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Jin Ho (+886-2-2703-1098, Peijin.Ho@onenessbio.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: 3 months after last dose (6 months after last dose only for the last MAD cohort)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.