clinical trial · NCT05965167
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
HypoparathyroidismOsteoporosisFractures, BoneOther DiseaseEBP05Forteo 0.02 mgEBP11EBP22EBP11-F2EBP11-F4EBP11-F1EBP11-F5
brief summary
The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with modified oral formulations (EBP11, EBP11-F1, EBP11-F2, EBP11-F4, EBP11-F5 and EBP22) versus three dose levels of Entera Bio's extensively studied oral EBP05 1.5 mg, 2.5 mg and 3.0 mg as well as the commercial Forteo 0.02 mg subcutaneous injection.
started
May 11, 2023
primary completion
Feb 8, 2026
completion
Feb 8, 2026
last updated
Feb 17, 2026
detailed description
Stated in summary, eligibility criteria and outcome measures
official title
A Phase 1b, Open-label, Partially Randomised Study to Assess Safety and Compare Pharmacokinetics of New Oral hPTH(1-34) Tablet Formulations vs. Oral EBP05 Tablets and Subcutaneous Forteo® Injection in Healthy Male Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol