A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Study Overview
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Brief Summary
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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

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

Conditions
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Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
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* Drug: VSA003
* Drug: 0.9% NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSA003<br>single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg | Drug: VSA003<br>* sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg<br>|
| Placebo Comparator: placebo<br>sterile normal saline (0.9% NaCl) calculated volume to match active treatment | Drug: 0.9% NaCl<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Up to 48 hours post dose | 
| Apparent terminal phase half-life (t1/2) of VSA003 | PK | 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 | PK | Up to 48 hours post dose | 
| Apparent clearance (CL/F) of VSA003 | PK | Up to 48 hours post dose | 
| Apparent terminal phase volume of distribution (Vz/F) of VSA003 | PK | Up to 48 hours post dose | 
| Change of fasting serum ANGPTL3 from pre-dose baseline | PD | Up to 85±3 days post-dose | 
| Anti-drug Antibodies (ADA) to VSA003 | immunogenecity | Up to 85±3 days post-dose |