Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:22 PM
Study NCT ID:
NCT05965167
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
Sponsor:
Entera Bio Ltd.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-F2, EBP11-F4 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: