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A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect and Potential Efficacy of PS1 in Subjects

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Trial Profile

A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect and Potential Efficacy of PS1 in Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Apr 2024

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At a glance

  • Drugs PS 1 Pharmasaga (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; First in man
  • Sponsors Pharmasaga

    • Most Recent Events

    • 10 Apr 2024 Planned End Date changed from 1 Jun 2024 to 1 Jul 2025.
    • 10 Apr 2024 Planned primary completion date changed from 1 Jun 2024 to 1 Jul 2025.
    • 07 Dec 2023 Number of arms changed from 6 to 8. Experimental: MAD portion - Cohort 5 (25mg) and Cohort 8 (50mg) added to study protocol. Eligibility criteria amended to include subjects aged 18 to 80 years. Arms and interventions amended.

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