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A Trial to Assess TEV-56286 at Different Doses in Healthy Participants

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 4 of 8 changed
See other at-risk trials from Teva Branded Pharmaceutical Products R&D LLC

Record History

  1. Primary endpoint(s) modified Enrollment increased: 60 → 69 participants · Interventions modified · Trial arms changed: 5 → 6 · 1 morev5 Show 4 more changesShow less
    • Enrollment increased: 60 → 69 participants
    • Interventions modified
    • Trial arms changed: 5 → 6
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jun 29, 2026 to Jun 26, 2026v4
  3. Recruitment opened Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses. The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants. A secondary objective is to assess the safety of TEV-56286 and how well it is tolerated. The estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit. The estimated duration for participants in Part 2 with Multiple Ascending Dose is approximately 64 days; including up to 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
Trial Details
NCT Number NCT07674940
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Healthy Volunteers
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov