New drug VSA012 takes first step in human safety trial
NCT ID NCT06766929
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests VSA012, a drug that targets the complement system (part of the immune system), in 40 healthy volunteers. The main goal is to check safety and how the drug moves through the body after a single dose. It is a first step before testing in patients with complement-driven diseases like PNH.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VSA012
- What this could lead to
- If successful, this could pave the way for treating diseases like PNH where the complement system is overactive.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only tests safety and dosing, not whether the drug works for any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Jan 2025
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing to provide written informed consent and to comply with study requirements * Participants must be non-pregnant/non-lactating * Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. * Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 * No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results. Exclusion Criteria: * History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses * History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations * Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) * History of meningococcal infection
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Peking University Third Hospital
Beijing, Beijing Municipality, China
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