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

NCT05965167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Hypoparathyroidism
  • Osteoporosis
  • Fractures, Bone
  • Other Disease

Interventions

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

Sponsors & Collaborators

  • Entera Bio Ltd.

    lead INDUSTRY

Principal Investigators

  • Yosef Caraco, MD · Clinical Research Center Hadassah Ein Kerem Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965167 on ClinicalTrials.gov