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A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 8 words Study description expanded, about 3 words · Study title shortened, about 5 wordsv8 Show 2 more changesShow less
    • Study description expanded, about 3 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Aug 31, 2025 to Dec 31, 2027 Completion date: Mar 15, 2026 to Jul 15, 2028v7 Show 1 more changeShow less
    • Completion date: Mar 15, 2026 to Jul 15, 2028
  3. Secondary endpoints: details revised at 1 of 2 entries Eligibility criteria expanded, about 5 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 1 to 2 Interventions: APG-5918 (Drug), APG-5918 (Drug), Placebo (Drug), Placebo (Drug) to APG-5918 (Drug), Placebo (Drug) · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 1 of 2 entries · 1 morev5 Show 4 more changesShow less
    • Interventions: APG-5918 (Drug), APG-5918 (Drug), Placebo (Drug), Placebo (Drug) to APG-5918 (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Mar 15, 2023 to Mar 13, 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 115 to 105 Eligibility criteria shortened, about 27 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 27 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
Trial Details
NCT Number NCT05773586
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Anemia
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov