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A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety, Tolerability and Pharmacokinetics of SPR994 Following Single and Multiple Ascending Doses of SPR994 Administered Orally in Healthy Volunteers

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Trial Profile

A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety, Tolerability and Pharmacokinetics of SPR994 Following Single and Multiple Ascending Doses of SPR994 Administered Orally in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Tebipenem pivoxil (Primary) ; Tebipenem pivoxil
  • Indications Gram-negative infections; Haemophilus infections; Streptococcal infections; Urinary tract infections
  • Focus Adverse reactions; First in man
  • Sponsors Spero Therapeutics

    • Most Recent Events

    • 01 Jul 2019 Results assessing the safety,pharmacokinetics and food effect of Tebipenem pivoxil hydrobromide published in the Antimicrobial Agents and Chemotherapy
    • 17 Jun 2019 According to a Spero Therapeutics media release, data from this trial will be presented at the American Society of Microbiology (ASM) Microbe 2019 Conference.
    • 16 Apr 2019 Results assessing population PK modelling of the human Phase I to select the clinical dose for Phase III, clinical data presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases.

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