NCT05965167

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Entera Bio Ltd. · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Stated in summary, eligibility criteria and outcome measures

Conditions

• Hypoparathyroidism
• Osteoporosis
• Fractures, Bone
• Other Disease

Interventions

Type	Name	Description
DRUG	EBP05	Oral tablets
DRUG	Forteo 0.02 mg	Subcutaneous injection
DRUG	EBP11	Oral tablets
DRUG	EBP22	Oral tablets
DRUG	EBP11-F2	Oral tablets
DRUG	EBP11-F4	Oral tablets
DRUG	EBP11-F1	Oral tablets
DRUG	EBP11-F5	Oral tablets

Timeline

• Start date: 2023-05-11
• Primary completion: 2026-02-08
• Completion: 2026-02-08
• First posted: 2023-07-28
• Last updated: 2026-02-17

Locations

1 site across 1 country: Israel