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Completed

NCT Number: NCT05851066

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

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

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Key information

Conditions

Dyslipidemias Congenital, Hereditary, and Neonatal Diseases and Abnormalities Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSA003

Drug

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

0.9% NaCl

Drug

placebo

Primary outcomes

  1. Frequency and severity of adverse event (AE) and serious adverse event (SAE)

    Time frame: Up to 85±3 days post-dose

    safety and tolerability

Secondary outcomes

  1. Maximum observed concentration (Cmax) of VSA003

    Time frame: Up to 48 hours post dose

    pharmacokinetics (PK)

  2. Time of occurrence of Cmax (tmax) of VSA003

    Time frame: Up to 48 hours post dose

    PK

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

    Time frame: Up to 48 hours post dose

    PK

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

    Time frame: Up to 48 hours post dose

    PK

  5. Apparent clearance (CL/F) of VSA003

    Time frame: Up to 48 hours post dose

    PK

  6. Apparent terminal phase volume of distribution (Vz/F) of VSA003

    Time frame: Up to 48 hours post dose

    PK

  7. Change of fasting serum ANGPTL3 from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    PD

  8. Anti-drug Antibodies (ADA) to VSA003

    Time frame: Up to 85±3 days post-dose

    immunogenecity

Other outcomes

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

    Time frame: Up to 85±3 days post-dose

    Lipid profile

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

    Time frame: Up to 85±3 days post-dose

    Lipid profile

  3. Change of triglyceride (TG) from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    Lipid profile

  4. Change of high density lipoprotein cholesterol (HDL-C) from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    Lipid profile

  5. Change of fasting glucose from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    glucose metabolism

  6. Change of HbA1c from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    glucose metabolism

  7. Change of fasting C peptide from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    glucose metabolism

  8. Change of fasting insulin from pre-dose baseline

    Time frame: Up to 85±3 days post-dose

    glucose metabolism

Sponsors and collaborators

Lead sponsor

Visirna Therapeutics HK Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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