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Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess in Healthy Volunteers the Bioavailability and Pharmacokinetics Of 30 mg and 60 mg Oral Enteric Coated Capsules of Cepharanthine Dihydrochloride in Comparison to 6 mg Oral Cepharanthine Dihydrochloride Tablets

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Trial Profile

Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess in Healthy Volunteers the Bioavailability and Pharmacokinetics Of 30 mg and 60 mg Oral Enteric Coated Capsules of Cepharanthine Dihydrochloride in Comparison to 6 mg Oral Cepharanthine Dihydrochloride Tablets

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 21 Aug 2024

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At a glance

  • Drugs Cepharanthine (Primary)
  • Indications Cancer; Infections
  • Focus Adverse reactions; First in man

Most Recent Events

  • 19 Aug 2024 According to a PharmaTher media release, the company anticipates that once this trial is completed it will support Sairiyos submission of an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration to commence Phase 2 and Phase 3 clinical trials in the United States.
  • 15 May 2024 According to a PharmaTher media release, the company has submitted clinical trial application to the Australian Human Research Ethics Committee for review and potential approval to initiate a Phase 1 clinical study.
  • 01 May 2024 According to a PharmaTher media release, the company aims to conduct its first-in-human clinical study of PD-001 in Australia to capitalize on drug development incentives in Australia, which could earn a 43.5 percent rebate from the Australian Federal Government's Research and Development tax incentive program. Upon completion of the clinical study, Sairiyo intends to submit an Investigational New Drug application for PD-001 to the U.S.FDA to commence clinical trials.

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