Clinical trial NCT05851066: A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
Official title: A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dyslipidemias
Familial Hypercholesterolemia
Hypertriglyceridemia
Lead sponsor: Visirna Therapeutics HK Limited
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Frequency and severity of adverse event (AE) and serious adverse event (SAE)
timeFrame: Up to 85±3 days post-dose
Secondary outcomes:
measure: Maximum observed concentration (Cmax) of VSA003
timeFrame: Up to 48 hours post dose
measure: Time of occurrence of Cmax (tmax) of VSA003
timeFrame: Up to 48 hours post dose
measure: Apparent terminal phase half-life (t1/2) of VSA003
timeFrame: Up to 48 hours post dose
measure: Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003
timeFrame: Up to 48 hours post dose
measure: Apparent clearance (CL/F) of VSA003
timeFrame: Up to 48 hours post dose
measure: Apparent terminal phase volume of distribution (Vz/F) of VSA003
timeFrame: Up to 48 hours post dose
measure: Change of fasting serum ANGPTL3 from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Anti-drug Antibodies (ADA) to VSA003
timeFrame: Up to 85±3 days post-dose
Other outcomes:
measure: Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of total cholesterol (TC) from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of triglyceride (TG) from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of high density lipoprotein cholesterol (HDL-C) from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of fasting glucose from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of HbA1c from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of fasting C peptide from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
measure: Change of fasting insulin from pre-dose baseline
timeFrame: Up to 85±3 days post-dose
Locations:
Study officials:
References: