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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:
• Healthy male subjects, 18 - 35 years of age, inclusive, at screening.
• Continuous nonsmoker who has not used nicotine containing products (including e-cigarettes, vapors, etc.) for at least 12 months prior to first dosing and throughout the study, based on subject self-reporting.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
• Medically healthy with no clinically significant medical condition, physical examination, laboratory profiles, vital signs, orthostatic vital sign measurements, or ECGs, as deemed by the PI or designee to be relevant to the study and does not pose an additional risk to the subject by their participation in the study.
• Understands the study procedures described in the Informed Consent Form (ICF), be willing and able to comply with the protocol, and provides written consent.
Locations
Other Locations
Israel
Clinical Research Center Hadassah Ein Kerem Medical Center
RECRUITING
Jerusalem
Contact Information
Primary
Clinical Operations at Entera Bio
INFO@ENTERABIO.COM
+972-2-571-7364
Time Frame
Start Date:2023-05-11
Estimated Completion Date:2026-05
Participants
Target number of participants:45
Treatments
Experimental: Treatment A EBP05 2.5 mg
Single dose of oral EBP05 2.5 mg
Experimental: Treatment B EBP05 1.5 mg
Single dose of oral EBP05 1.5 mg
Experimental: Treatment C Forteo 0.02 mg
Single SC injection of Forteo 0.02 mg
Experimental: Treatment D EBP11 1.5 mg
Single dose of oral EBP11 1.5 mg
Experimental: Treatment E EBP11 BID (dose determined after IA)
BID administration of oral EBP11 2.5 mg tablets
Experimental: Treatment F EBP11 BID (dose determined after IA)
BID administration of oral EBP11 tablets 1.5 mg tablets (3 x 0.5 mg tablets) as first dose and 2.5 mg (5 x 0.5 mg tablets) as second dose.
Experimental: Treatment G EBP11 1.5 mg
Single dose of oral EBP11 1.5 mg
Experimental: Treatment I EBP22 1.5 mg
Single dose of oral EBP22 1.5 mg
Experimental: Treatment J EBP22 1.5 mg
Single dose of oral EBP22 1.5 mg
Experimental: Treatment K EBP05 1.5 mg
Single dose of oral EBP05 1.5 mg
Experimental: Treatment L EBP05 2.5 mg
Single dose of oral EBP05 2.5 mg
Experimental: Treatment M Forteo 0.02 mg
Single SC injection of Forteo 0.02 mg
Experimental: Treatment N EBP05 3.0 mg
Single dose of oral EBP05 3.0 mg
Experimental: Treatment H EBP22 2.5 mg (5 x 0.5 mg).