A Phase I, interwoven, first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of A3907, a first-in-class IBAT inhibitor
Latest Information Update: 28 Dec 2023
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At a glance
- Drugs A 3907 (Primary)
- Indications Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis
- Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
- Sponsors Albireo Pharma
- 14 Nov 2023 Results assessing the lipidomic modulation of the systemic apical BA transporter inhibitor A3907 in liver and plasma from subjects and matched this to NASH patients for translational validity, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
- 22 Feb 2022 Status changed from recruiting to completed, according to an Albireo Pharma media release.
- 16 Dec 2021 According to an Albireo Pharma media release, the Phase 1 trial was a randomized, double-blind, placebo-controlled, single and seven day multiple-dose study was conducted in 54 and 22, respectively, healthy subjects. Doses evaluated were 1-162 mg in the single ascending dose portion, and 9-67.5 mg in the multiple ascending dose portion