Vigonvita opens dosing in early Phase 1 study of oral VV913 in China
The multiple-ascending-dose trial in healthy male volunteers now needs to show a clean safety and pharmacokinetic profile through year-end to support any move into patients.
Executive Summary
- Vigonvita Life Sciences has begun active dosing in a multiple-ascending-dose study of its oral small molecule VV913, moving the trial from not-yet-recruiting to actively recruiting status.
- The study is built entirely around pharmacokinetics and tolerability in healthy male volunteers, the standard early step before any disease-population testing can begin.
- The sponsor is running the study to its original enrollment target with no scale-back, and its track record across dozens of prior trials shows consistent completion rather than early termination.
- VV913's target and mechanism are not established in the available competitive data, so the study sits among a broad field of early-stage small-molecule programs in healthy volunteers without a specific mechanistic rival.
The status change
The trial, registered as NCT07507838, is a Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules, run in China by Vigonvita Life Sciences. The registry recorded the status change from Not yet recruiting to Recruiting on July 14, 2026, alongside an update to the actual start date of April 13, 2026. The trial is designed as a randomized, placebo-controlled study of oral VV913 in adult male volunteers, with an Experimental arm and a Placebo Comparator arm. NCT07507838+1Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 CapsulesNCT07507838Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 CapsulesJul 14, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The endpoint bar
The study carries eleven primary endpoints, all pharmacokinetic or safety measures: area under the plasma concentration curve (AUC0-24h and AUC0-infinity), maximum plasma concentration (Cmax), apparent clearance, accumulation ratio, time to maximum concentration, volume of distribution, mean residence time, half-life, elimination rate constant, and the incidence of treatment-emergent adverse events. These measures, tracked from baseline through 72 hours after the last dose for the pharmacokinetic endpoints and six days for safety, will establish how VV913 behaves in the body across ascending doses and whether repeated dosing produces tolerable adverse-event rates. No results have posted on ClinicalTrials.gov for this study. NCT07507838Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 CapsulesNCT07507838
Enrollment and stability
The trial targets 24 participants, unchanged from its original anticipated enrollment, and its primary completion date remains December 31, 2026, the same date carried since the study was first registered. An enrollment hold at target in an early Phase 1 design is a routine operational signal, not a change in trial scope. The protocol has logged only the addition of the study record and the single status update since April 2026, a pattern the registry-churn proxy classifies as Stable. NCT07507838Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 CapsulesNCT07507838
Sponsor and pipeline context
Vigonvita Life Sciences is running a second trial of VV913, a Phase 1 safety, tolerability, and pharmacokinetics study in Chinese healthy participants (NCT07372703) that targets a primary completion date of September 1, 2026, ahead of this multiple-ascending-dose study. Across its full portfolio, Vigonvita has completed all 25 of its prior trials with no terminations recorded. No competitor in the broader early-stage small-molecule field tested in healthy volunteers shares VV913's target or mechanism class, since that information is not established in the competitive data; the nearest comparators, including programs from AbbVie, Basilea Pharmaceutica, and Eli Lilly, share only the modality and the healthy-volunteer setting, not the mechanism.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.