CompletedPhase 1

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

China36 participantsStarted 2023-06-01

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to 85±3 days post-dose

Trial details

NCT IDNCT05851066

SponsorVisirna Therapeutics HK Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-07

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