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Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Dec 2025 → Oct 2026
See other at-risk trials from Vigonvita Life Sciences

Record History

  1. Primary and study completion pushed from Dec 2025 to Oct 2026 Enrollment closed, study ongoing · Site details revisedv8 Show 2 more changesShow less
    • Enrollment closed, study ongoing
    • Site details revised
  2. Primary endpoints: 13 to 26 Enrollment target: 78 to 82 · Study description expanded, about 1 wordv7 Show 2 more changesShow less
    • Enrollment target: 78 to 82
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Dec 2024 to Dec 2025v6
  4. Primary and study completion dates: Apr 2024 to Dec 2024v5
  5. Enrollment target: 70 to 78 Secondary endpoints: 4 to 1 · Site contact updated · Eligibility criteria expanded, about 4 wordsv4 Show 3 more changesShow less
    • Secondary endpoints: 4 to 1
    • Site contact updated
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria shortened, about 64 words Secondary endpoints: details revised at 1 of 4 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2023 to Oct 27, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2023 to Oct 27, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
Trial Details
NCT Number NCT06105151
Lead Sponsor Vigonvita Life Sciences
Conditions Schizophrenia
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov