Back to resultsA VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
Primary Purpose
Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
VSA003
0.9% NaCl
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VSA003
placebo
Arm Description
single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg
sterile normal saline (0.9% NaCl) calculated volume to match active treatment
Outcomes
Primary Outcome Measures
Frequency and severity of adverse event (AE) and serious adverse event (SAE)
safety and tolerability
Secondary Outcome Measures
Maximum observed concentration (Cmax) of VSA003
pharmacokinetics (PK)
Time of occurrence of Cmax (tmax) of VSA003
PK
Apparent terminal phase half-life (t1/2) of VSA003
PK
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003
PK
Apparent clearance (CL/F) of VSA003
PK
Apparent terminal phase volume of distribution (Vz/F) of VSA003
PK
Change of fasting serum ANGPTL3 from pre-dose baseline
PD
Anti-drug Antibodies (ADA) to VSA003
immunogenecity
Full Information
NCT ID
NCT05851066
First Posted
April 26, 2023
Last Updated
May 9, 2023
Sponsor
Visirna Therapeutics HK Limited
1. Study Identification
Unique Protocol Identification Number
NCT05851066
Brief Title
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
Official Title
A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visirna Therapeutics HK Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VSA003
Arm Type
Experimental
Arm Description
single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sterile normal saline (0.9% NaCl) calculated volume to match active treatment
Intervention Type
Drug
Intervention Name(s)
VSA003
Intervention Description
sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Frequency and severity of adverse event (AE) and serious adverse event (SAE)
Description
safety and tolerability
Time Frame
Up to 85±3 days post-dose
Secondary Outcome Measure Information:
Title
Maximum observed concentration (Cmax) of VSA003
Description
pharmacokinetics (PK)
Time Frame
Up to 48 hours post dose
Title
Time of occurrence of Cmax (tmax) of VSA003
Description
PK
Time Frame
Up to 48 hours post dose
Title
Apparent terminal phase half-life (t1/2) of VSA003
Description
PK
Time Frame
Up to 48 hours post dose
Title
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003
Description
PK
Time Frame
Up to 48 hours post dose
Title
Apparent clearance (CL/F) of VSA003
Description
PK
Time Frame
Up to 48 hours post dose
Title
Apparent terminal phase volume of distribution (Vz/F) of VSA003
Description
PK
Time Frame
Up to 48 hours post dose
Title
Change of fasting serum ANGPTL3 from pre-dose baseline
Description
PD
Time Frame
Up to 85±3 days post-dose
Title
Anti-drug Antibodies (ADA) to VSA003
Description
immunogenecity
Time Frame
Up to 85±3 days post-dose
Other Pre-specified Outcome Measures:
Title
Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline
Description
Lipid profile
Time Frame
Up to 85±3 days post-dose
Title
Change of total cholesterol (TC) from pre-dose baseline
Description
Lipid profile
Time Frame
Up to 85±3 days post-dose
Title
Change of triglyceride (TG) from pre-dose baseline
Description
Lipid profile
Time Frame
Up to 85±3 days post-dose
Title
Change of high density lipoprotein cholesterol (HDL-C) from pre-dose baseline
Description
Lipid profile
Time Frame
Up to 85±3 days post-dose
Title
Change of fasting glucose from pre-dose baseline
Description
glucose metabolism
Time Frame
Up to 85±3 days post-dose
Title
Change of HbA1c from pre-dose baseline
Description
glucose metabolism
Time Frame
Up to 85±3 days post-dose
Title
Change of fasting C peptide from pre-dose baseline
Description
glucose metabolism
Time Frame
Up to 85±3 days post-dose
Title
Change of fasting insulin from pre-dose baseline
Description
glucose metabolism
Time Frame
Up to 85±3 days post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Zhu
Phone
+86-18616577428
Email
amy.zhu@visirna.com
12. IPD Sharing Statement
Learn more about this trial
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
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