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COMPLETEDPHASE1

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers

NCT05851066•Visirna Therapeutics HK Limited

View on ClinicalTrials.gov

Summary

This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
•BMI 18.0\~28.0 kg/m2
•Willing to provide written informed consent and to comply with study requirements
•On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
•TG\> 100 mg/dL
•LDL-C\> 70 mg/dL

Exclusion Criteria

•Clinically significant health concerns
•Regular use of alcohol within one month prior to screening
•Recent (within 3 months) use of illicit drugs
•Female with pregnancy or breastfeeding
•QTcF\>450 ms in ECG
•Donation or loss of whole blood more than 400 ml prior to administration of the study treatment

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 1, 2023

Primary Completion Date

May 7, 2024

Completion Date

May 7, 2024

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

DyslipidemiasFamilial HypercholesterolemiaHypertriglyceridemia

Interventions

VSA003

DRUG

0.9% NaCl

DRUG

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

Heterozygous Familial Hypercholesterolemia (HeFH)

View study

RECRUITINGPHASE3

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

NCT06822790

Hypertriglyceridemia

View study

RECRUITING

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease

To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults