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Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 9 words
  2. Re-verified, no change to tracked fieldsv12
  3. Primary completion date: Nov 18, 2026 to Nov 16, 2026 Completion date: Mar 9, 2027 to Mar 18, 2027 · Eligibility criteria expanded, about 33 wordsv11 Show 2 more changesShow less
    • Completion date: Mar 9, 2027 to Mar 18, 2027
    • Eligibility criteria expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  4. 3 versions Re-verified since Mar 3, 2026, no change to tracked fieldsv8-v10
  5. Trial status: Suspended to Recruiting Primary endpoints: 4 to 2 · Enrollment target: 54 to 49 · Primary completion date: Mar 8, 2027 to Nov 18, 2026 · 4 morev7 Show 7 more changesShow less
    • Primary endpoints: 4 to 2
    • Enrollment target: 54 to 49
    • Primary completion date: Mar 8, 2027 to Nov 18, 2026
    • Completion date: Mar 31, 2028 to Mar 9, 2027
    • Secondary endpoints revised (2)
    • Site details revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Dec 15, 2025 to Mar 8, 2027 Completion date: Dec 15, 2025 to Mar 31, 2028v6 Show 1 more changeShow less
    • Completion date: Dec 15, 2025 to Mar 31, 2028
  2. Trial status: Recruiting to Suspended Sponsor's reason: Sponsor decision Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  3. 2 versions Re-verified since Nov 7, 2024, no change to tracked fieldsv3-v4
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 5, 2024 to Sep 12, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 5, 2024 to Sep 12, 2024
    • 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Merck KGaA
43 trials monitored
See 4 trials at risk
The present study in healthy participants will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) of subcutaneously administered M5542.
Trial Details
NCT Number NCT06577337
Lead Sponsor Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions Healthy
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov