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Status Change

Vigonvita opens enrollment in Phase 1 food-effect study of VV913 capsules

The Chinese trial will test how a meal changes VV913 absorption in healthy volunteers, a routine step before the drug can move into dosing studies that matter more.

Trial NCT07565792

Executive Summary

  • A small Vigonvita Life Sciences trial testing how food affects absorption of its oral drug candidate VV913 has opened enrollment, moving from a planned to an active recruiting status.
  • The study exists to answer a pharmacokinetic question, not a clinical one: whether eating changes how much VV913 gets into the bloodstream and how fast, information that shapes dosing instructions rather than efficacy claims.
  • VV913 is also being tested in two other early-stage healthy-volunteer studies, giving the sponsor a broader pharmacokinetic and safety base to draw on as the program advances.
  • No mechanism of action or target has been characterized for VV913, so this study says nothing yet about how the drug works in disease, only how the body handles it after a meal.

The trial

NCT07565792 moved from Not yet recruiting to Recruiting status on July 14, 2026, according to its ClinicalTrials.gov record. The study, titled "Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers," is a Phase 1 interventional trial run in China with a target enrollment of 12 adult male healthy volunteers. Its four primary endpoints are pharmacokinetic and safety measures: area under the plasma concentration curve from time zero to 72 hours (AUC0-t), area under the curve extrapolated to infinity (AUC0-∞), maximum plasma concentration (Cmax), and incidence of adverse events, tracked from dosing through four days after the last dose. NCT07565792Study of Food Effects of VV913 Capsules in Chinese Healthy VolunteersNCT07565792

Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.

Endpoint Met4%
Completes98%
Clinical Significance0%
Regulatory46%

What the design tests

A food-effect study is standard pharmacokinetic housekeeping for an oral drug: it establishes whether patients need to take the capsule with or without food, and whether a meal meaningfully shifts how much drug reaches circulation. The trial is not registrational and enrolls only healthy volunteers, so it cannot speak to efficacy in any disease population. Its primary completion date is set for December 31, 2026, unchanged since the study's initial registration. NCT07565792Study of Food Effects of VV913 Capsules in Chinese Healthy VolunteersNCT07565792

Operational read

The status change is the only protocol event recorded since the trial was first submitted on May 4, 2026, and enrollment has not moved from its original target of 12 participants, a change the trial's own operational model classifies as within the routine band for a Phase 1 study. Protocol-stability tracking shows zero amendments beyond the status update, and the trial's registry-churn profile reads as Stable. The study started recruitment on May 11, 2026, roughly on the timeline implied by its initial registration. NCT07565792Study of Food Effects of VV913 Capsules in Chinese Healthy VolunteersNCT07565792

The broader program

Vigonvita Life Sciences is running VV913 across three active trials, all in Phase 1 or earlier and all in healthy volunteers: this food-effect study, a multiple-ascending-dose safety and pharmacokinetics study (NCT07507838, targeting 24 participants against placebo), and a safety, tolerability, and pharmacokinetics study (NCT07372703, targeting 56 participants against placebo, with a primary completion date of September 1, 2026). None have posted results. The sponsor has completed 25 prior trials with no terminations on record, a track record that speaks to execution discipline but says nothing about whether VV913 itself will clear any clinical bar. NCT07565792Study of Food Effects of VV913 Capsules in Chinese Healthy VolunteersNCT07565792

What is not yet known

VV913's mechanism of action and molecular target have not been characterized in the available registry data, so no competitive or first-in-class framing can be drawn from this event. The trial's own primary result, whether a meal shifts AUC0-t, AUC0-∞, or Cmax outside a bioequivalence range, and what adverse events accompany dosing, will not be known until the study reaches its December 31, 2026 primary completion date. NCT07565792Study of Food Effects of VV913 Capsules in Chinese Healthy VolunteersNCT07565792

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.