Assess the Safety and Tolerability of SNS851 in Study Participants
ConditionMetabolic Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOneness Biotech Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SNS851
DrugSNS851 is a potent siRNA treatment targeting metabolic diseases.
Placebo
Other interventionNormal saline
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: SNS851Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
Incidence of Treatment-Related Adverse Events
Time frame
3 months after last dose (6 months after last dose only for the last MAD cohort)4
Incidence of Serious Adverse Events (SAEs)
Time frame
3 months after last dose (6 months after last dose only for the last MAD cohort)Sponsors and contacts
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Source ClinicalTrials.gov