A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

NCT05851066 | Completed Phase 1

• 1 other identifier: VSA003-1001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse event (AE) and serious adverse event (SAE)

  safety and tolerability

  Up to 85±3 days post-dose

Secondary Outcomes (8)

• Maximum observed concentration (Cmax) of VSA003

  Up to 48 hours post dose

• Time of occurrence of Cmax (tmax) of VSA003

  Up to 48 hours post dose

• Apparent terminal phase half-life (t1/2) of VSA003

  Up to 48 hours post dose

• Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003

  Up to 48 hours post dose

• Apparent clearance (CL/F) of VSA003

  Up to 48 hours post dose

Other Outcomes (8)

• Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline

  Up to 85±3 days post-dose

• Change of total cholesterol (TC) from pre-dose baseline

  Up to 85±3 days post-dose

• Change of triglyceride (TG) from pre-dose baseline

  Up to 85±3 days post-dose

Study Arms (2)

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

VSA003 DRUG

sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg

VSA003

0.9% NaCl DRUG

placebo

placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Visirna Therapeutics HK Limited: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Dyslipidemias; Hyperlipoproteinemia Type II; Hypertriglyceridemia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2023
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)