A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Visirna Therapeutics

Status and phase: Completed; Phase 1

Conditions: Dyslipidemias; Hypertriglyceridemia; Familial Hypercholesterolemia

Treatments: Drug: 0.9% NaCl; Drug: VSA003

Study type: Interventional

Funder types: Industry

Identifiers

NCT05851066

VSA003-1001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

VSA003

Experimental group

Description:

single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg

Treatment:

Drug: VSA003

placebo

Placebo Comparator group

Description:

sterile normal saline (0.9% NaCl) calculated volume to match active treatment

Treatment:

Drug: 0.9% NaCl