A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05851066
• Other study ID #: VSA003-1001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Visirna Therapeutics HK Limited
• Contact: Min Zhu
• Phone: +86-18616577428
• Email: amy.zhu[@]visirna.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II
• Hypertriglyceridemia

Intervention

Drug:
• VSA003
sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg
• 0.9% NaCl
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Visirna Therapeutics HK Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline	Lipid profile	Up to 85±3 days post-dose
Other	Change of total cholesterol (TC) from pre-dose baseline	Lipid profile	Up to 85±3 days post-dose
Other	Change of triglyceride (TG) from pre-dose baseline	Lipid profile	Up to 85±3 days post-dose
Other	Change of high density lipoprotein cholesterol (HDL-C) from pre-dose baseline	Lipid profile	Up to 85±3 days post-dose
Other	Change of fasting glucose from pre-dose baseline	glucose metabolism	Up to 85±3 days post-dose
Other	Change of HbA1c from pre-dose baseline	glucose metabolism	Up to 85±3 days post-dose
Other	Change of fasting C peptide from pre-dose baseline	glucose metabolism	Up to 85±3 days post-dose
Other	Change of fasting insulin from pre-dose baseline	glucose metabolism	Up to 85±3 days post-dose
Primary	Frequency and severity of adverse event (AE) and serious adverse event (SAE)	safety and tolerability	Up to 85±3 days post-dose
Secondary	Maximum observed concentration (Cmax) of VSA003	pharmacokinetics (PK)	Up to 48 hours post dose
Secondary	Time of occurrence of Cmax (tmax) of VSA003	PK	Up to 48 hours post dose
Secondary	Apparent terminal phase half-life (t1/2) of VSA003	PK	Up to 48 hours post dose
Secondary	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
Secondary	Apparent clearance (CL/F) of VSA003	PK	Up to 48 hours post dose
Secondary	Apparent terminal phase volume of distribution (Vz/F) of VSA003	PK	Up to 48 hours post dose
Secondary	Change of fasting serum ANGPTL3 from pre-dose baseline	PD	Up to 85±3 days post-dose
Secondary	Anti-drug Antibodies (ADA) to VSA003	immunogenecity	Up to 85±3 days post-dose