A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Phase 1

Not yet recruiting

• Conditions: Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia
• Interventions: Drug: VSA003; Drug: 0.9% NaCl

• Registration Number: NCT05851066
• Lead Sponsor: Visirna Therapeutics HK Limited

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-26
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-09
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Study Start: 2023-06
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
VSA003	VSA003	single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg
placebo	0.9% NaCl	sterile normal saline (0.9% NaCl) calculated volume to match active treatment

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse event (AE) and serious adverse event (SAE)	Up to 85±3 days post-dose	safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax) of VSA003	Up to 48 hours post dose	pharmacokinetics (PK)
Time of occurrence of Cmax (tmax) of VSA003	Up to 48 hours post dose	PK
Apparent terminal phase half-life (t1/2) of VSA003	Up to 48 hours post dose	PK
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	PK
Apparent clearance (CL/F) of VSA003	Up to 48 hours post dose	PK
Apparent terminal phase volume of distribution (Vz/F) of VSA003	Up to 48 hours post dose	PK
Change of fasting serum ANGPTL3 from pre-dose baseline	Up to 85±3 days post-dose	PD
Anti-drug Antibodies (ADA) to VSA003	Up to 85±3 days post-dose	immunogenecity