NCT05851066CompletedPhase 1
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 26 Apr 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 7 May 2024
- Lead sponsor
- Visirna Therapeutics HK Limited
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05851066
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 1 Jun 2023 to the primary completion date, 7 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular use of alcohol within one month prior to screening
- Recent (within 3 months) use of illicit drugs
- 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
Other
- Clinically significant health concerns
- Female with pregnancy or breastfeeding
- QTcF\>450 ms in ECG
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.