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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Visirna Therapeutics HK Limited

Criteria

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