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A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses in healthy participants.
Conditions:
🦠 Pain
🗓️ Study Start (Actual) 9 May 2024
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) May 2025
👥 Enrollment (Estimated) 110
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Lenexa, Kansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
    • * A total body weight of more than (\>) 50 kg
    • * Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

    Exclusion Criteria:

    • * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug.
    • * Any condition possibly affecting drug distribution, metabolism, or excretion
    • Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 April 2024
  • First Submitted that Met QC Criteria 26 April 2024
  • First Posted 1 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 May 2024
  • Last Update Posted 30 May 2024
  • Last Verified April 2024
I'm interested ...!!