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A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT05851066
Recruitment Status : Not yet recruiting
First Posted : May 9, 2023
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Visirna Therapeutics HK Limited

Study Description
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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

Condition or disease Intervention/treatment Phase
Dyslipidemias Familial Hypercholesterolemia Hypertriglyceridemia Drug: VSA003 Drug: 0.9% NaCl Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VSA003
single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg
 Drug: VSA003
sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg
Placebo Comparator: placebo
sterile normal saline (0.9% NaCl) calculated volume to match active treatment
 Drug: 0.9% NaCl
placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05851066


Contacts
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Contact: Min Zhu +86-18616577428 amy.zhu@visirna.com

Sponsors and Collaborators
Visirna Therapeutics HK Limited
More Information
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Responsible Party: Visirna Therapeutics HK Limited
ClinicalTrials.gov Identifier: NCT05851066    
Other Study ID Numbers: VSA003-1001
First Posted: May 9, 2023    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Dyslipidemias
Hypertriglyceridemia
Hyperlipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias