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A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

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Trial Profile

A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Jul 2021

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At a glance

  • Drugs AJM 347 (Primary)
  • Indications Inflammatory bowel diseases
  • Focus Adverse reactions; First in man
  • Sponsors EA Pharma

Most Recent Events

  • 23 May 2021 Results (n=160) assessing the safety, tolerability, food-effects, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of AJM347 in healthy male volunteers, presented at the Digestive Disease Week 2021.
  • 28 Aug 2018 Status changed from recruiting to completed.
  • 17 Jul 2018 Planned End Date changed from 1 Mar 2018 to 1 Sep 2019.

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