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A Randomized Double-Blind, Single-Dose, Placebo-Controlled Pharmacokinetic and Proof-of-Concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and the Analgesic Efficacy and Tolerability of CYT-1010 vs. Morphine in Subjects with Moderate to Severe Pain after Third Molar Extraction

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A Randomized Double-Blind, Single-Dose, Placebo-Controlled Pharmacokinetic and Proof-of-Concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and the Analgesic Efficacy and Tolerability of CYT-1010 vs. Morphine in Subjects with Moderate to Severe Pain after Third Molar Extraction

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 08 Feb 2019

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At a glance

  • Drugs CYT 1010 (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Adverse reactions; Proof of concept
  • Sponsors Cytogel

    • Most Recent Events

    • 08 Feb 2019 New trial record
    • 05 Feb 2019 According to a Cytogel media release, in response to the CYT-1010 Investigational New Drug (IND) application, the U.S. Food and Drug Administration (FDA) has issued authorization allowing this study to proceed. The FDA indicated that, upon completion of the study, the company should submit data to the FDA for advancing to higher doses of CYT-1010, hence a partial clinical hold (PCH) in development will be in effect. The data will be reviewed for the removal of PCH and allowance for higher doses.

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