A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers | NCT05851066

Studies
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

NCT05851066

Sponsor

Visirna Therapeutics HK Limited

Status

Completed

Last Update Posted

Sep 12, 2025Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Dyslipidemias
Familial Hypercholesterolemia
Hypertriglyceridemia

Interventions

VSA003
0.9% NaCl

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

May 7, 2024Actual

Completion Date

May 7, 2024Actual

First Submitted Date

Apr 26, 2023

First Submission Date that Met QC Criteria

May 5, 2023

First Posted Date

May 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2025

Last Update Posted Date

Sep 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VSA003	Experimental	single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg	Drug: VSA003
placebo	Placebo Comparator	sterile normal saline (0.9% NaCl) calculated volume to match active treatment	Drug: 0.9% NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VSA003	Drug	sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg	VSA003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and severity of adverse event (AE) and serious adverse event (SAE)	safety and tolerability	Up to 85±3 days post-dose

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed concentration (Cmax) of VSA003	pharmacokinetics (PK)	Up to 48 hours post dose
Time of occurrence of Cmax (tmax) of VSA003	PK

Other Outcomes

Measure	Description	Time Frame
Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline	Lipid profile	Up to 85±3 days post-dose
Change of total cholesterol (TC) from pre-dose baseline	Lipid profile

Eligibility Module

Eligibility Criteria

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

Note: additional inclusion/exclusion criteria may apply, per protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias
D006938	Hyperlipoproteinemia Type II
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D008052	Lipid Metabolism, Inborn Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided