A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Visirna Therapeutics HK Limited36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dyslipidemias Familial Hypercholesterolemia Hypertriglyceridemia

Interventions

VSA003DRUG

sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg

0.9% NaClDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Frequency and severity of adverse event (AE) and serious adverse event (SAE)

safety and tolerability

Time frame: Up to 85±3 days post-dose