Assess the Safety and Tolerability of SNS851 in Healthy Participants

NCT07417124 | Recruiting Phase 1

• 1 other identifier: SNS851CLCT01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

  3 months after last dose (6 months after last dose only for the last MAD cohort)

• Incidence of withdrawals due to Adverse Events (AEs)

  3 months after last dose (6 months after last dose only for the last MAD cohort)

• Incidence of Treatment-Related Adverse Events

  3 months after last dose (6 months after last dose only for the last MAD cohort)

• Incidence of Serious Adverse Events (SAEs)

  3 months after last dose (6 months after last dose only for the last MAD cohort)

Study Arms (2)

SNS851

EXPERIMENTAL

Eligible participants will be assigned to receive low-high single or multiple doses of the investigational drug.

Drug: SNS851

Placebo

PLACEBO COMPARATOR

Eligible participants will be assigned to single or multiple doses of the placebo.

Other: Placebo

Interventions

SNS851 DRUG

SNS851 is a potent siRNA treatment targeting metabolic diseases.

SNS851

Placebo OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (1)

Veritus Research

Melbourne, Australia

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Pei-Jin Ho

CONTACT

+886-2-2703-1098; Peijin.Ho@onenessbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

AU (1)