drugset
drugset / Trial / NCT05965167

Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo

NCT05965167 ↗

Phase 1 Completed 45 enrolled Entera Bio Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2023-05-11
Primary completion
2026-02-08
Completion
2026-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject EBP05 Unknown 1.5 mg Oral
Subject EBP05 Unknown 2.5 mg Oral
Subject EBP05 Unknown 3 mg Oral
Subject EBP11 Unknown 1.5 mg Oral
Subject EBP11 Unknown 2.5 mg Oral
Subject EBP11-F1 Unknown 1 mg Oral
Subject EBP11-F2 Unknown 1.5 mg Oral
Subject EBP11-F4 Unknown 2.5 mg Oral
Subject EBP11-F5 Unknown 3 mg Oral
Subject EBP22 Unknown 1.5 mg Oral
Subject EBP22 Unknown 2.5 mg Oral
Subject Teriparatide Protein / enzyme biologic 0.02 mg Subcutaneous

Indications

disease of bone structure hypoparathyroidism osteoporosis