A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers (NCT05851066) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and severity of adverse event (AE) and serious adverse event (SAE)