HypoparathyroidismPhase 1NCT05965167
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
A Phase 1 study testing EBP05, Forteo 0.02 mg and EBP11 in people with Hypoparathyroidism and Osteoporosis, run by Entera Bio Ltd. at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism, Osteoporosis, Fractures, Bone
- What is being tested?
- EBP05, Forteo 0.02 mg and EBP11
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 11 May 2023to 8 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History or current condition of mental instability or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.
- Active gastrointestinal inflammatory disorder, gastrointestinal motility disorders, and chronic gastritis, including but not limited to: ulcerative colitis, Crohn's disease, irritable bowel syndrome, short bowel syndrome, celiac disease, gastroparesis, that may affect drug bioavailability.
- Any conditions or factors that, in the judgment of the PI or designee, somehow may impact gastrointestinal absorption, distribution or metabolism of parathyroid hormone analogues, or known to potentiate or predispose to undesired effects.
- History of significant gastrointestinal, liver or kidney disease, or gastrointestinal surgery (including bariatric surgery, or any other interventional procedures with stomach and intestinal tract) that may affect either drug bioavailability, or hPTH(1-34) or SNAC metabolism.
- History or presence of alcohol or drug abuse or positive urine drug or blood alcohol results at screening.
- Known allergies or sensitivities to components of the Study Medication (e.g. soy) or known hypersensitivity to PTH or hPTH(1-34).
Show all 27Show fewer
- History or presence of clinically significant:
- Urolithiasis;
- Angina at Screening, in the opinion of the PI;
- Hypocalcemia or hypercalcemia at screening;
- Personal or family history of congenital long QT syndrome or known family history of sudden death.
- Subjects with ECG findings deemed abnormal with clinical significance by the PI or designee at screening for the following:
- QTcF interval > 470 msec;
- PR > 220 msec;
- QRS > 120 msec.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 90 systolic or 40 diastolic mmHg or greater than 140 systolic or 90 diastolic mmHg at screening;
- Orthostatic vital sign results with a decrease in systolic > 20 mmHg or decrease in diastolic > 10 mm Hg, and/or increase in heart rate of > 20 beats per minute at screening or Day 1 check-in.
- Seated heart rate is lower than 50 bpm or higher than 99 bpm at screening (when clinically significant as determined by PI).
- Estimated creatinine clearance < 80 mL/min at screening
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements that should be taken on the treatment visit day before the dosing of Study Medication and 2 hours after the dosing of Study Medication.
- H2 blocker or PPI or antacid (including prescription and nonprescription) three days before the dosing of the Study Medication and 2 hours after the dosing of Study Medication.
- Donation of blood or significant blood loss within 56 days prior to first dosing.
- Hemoglobin levels below 13 g/dL at screening or at in screening test done during the study.
- Plasma donation within 7 days prior to first dosing.
- Participation in another interventional clinical study within 30 days prior to screening visit.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Clinical Research Center Hadassah Ein Kerem Medical Center
Jerusalem, 91120,
About this study
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
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.
Read the detailed description
Stated in summary, eligibility criteria and outcome measures
- Conditions
- Hypoparathyroidism, Osteoporosis, Fractures, Bone, Other Disease
- Being tested
- EBP05, Forteo 0.02 mg, EBP11, EBP22, EBP11-F2
- Keywords
- Hypoparathyroidism, PTH(1-34), Parathyroid Hormone, Teriparatide, Osteoporosis
- Medical subject headings
- Hypoparathyroidism, Osteoporosis, Fractures, Bone, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBP05Drug
Also called hPTH(1-34)
Oral tablets
Forteo 0.02 mgDrug
Also called hPTH(1-34)
Subcutaneous injection
EBP11Drug
Also called hPTH(1-34)
Oral tablets
EBP22Drug
Also called hPTH(1-34)
Oral tablets
EBP11-F2Drug
Also called hPTH(1-34)
Oral tablets
EBP11-F4Drug
Also called hPTH(1-34)
Oral tablets
EBP11-F1Drug
Also called hPTH(1-34)
Oral tablets
EBP11-F5Drug
Also called hPTH(1-34)
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment A EBP05 2.5 mg | Experimental | Single dose of oral EBP05 2.5 mg Receives: Drug: EBP05 |
| Treatment B EBP05 1.5 mg | Experimental | Single dose of oral EBP05 1.5 mg Receives: Drug: EBP05 |
| Treatment C Forteo 0.02 mg | Experimental | Single SC injection of Forteo 0.02 mg Receives: Drug: Forteo 0.02 mg |
| Treatment D EBP11 1.5 mg | Experimental | Single dose of oral EBP11 1.5 mg Receives: Drug: EBP11 |
| Treatment E EBP11 BID (dose determined after IA) | Experimental | BID administration of oral EBP11 2.5 mg tablets Receives: Drug: EBP11 |
| Treatment F EBP11 BID (dose determined after IA) | Experimental | 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. Receives: Drug: EBP11 |
| Treatment G EBP11 1.5 mg | Experimental | Single dose of oral EBP11 1.5 mg Receives: Drug: EBP11 |
| Treatment I EBP22 1.5 mg | Experimental | Single dose of oral EBP22 1.5 mg Receives: Drug: EBP22 |
| Treatment J EBP22 1.5 mg | Experimental | Single dose of oral EBP22 1.5 mg Receives: Drug: EBP22 |
| Treatment K EBP05 1.5 mg | Experimental | Single dose of oral EBP05 1.5 mg Receives: Drug: EBP05 |
| Treatment L EBP05 2.5 mg | Experimental | Single dose of oral EBP05 2.5 mg Receives: Drug: EBP05 |
| Treatment M Forteo 0.02 mg | Experimental | Single SC injection of Forteo 0.02 mg Receives: Drug: Forteo 0.02 mg |
| Treatment N EBP05 3.0 mg | Experimental | Single dose of oral EBP05 3.0 mg Receives: Drug: EBP05 |
| Treatment H EBP22 2.5 mg (5 x 0.5 mg tablets) | Experimental | Single dose of oral EBP22 2.5 mg (5 x 0.5 mg tablets) Receives: Drug: EBP22 |
| Treatment O EBP11-F4 2.5 mg | Experimental | Single dose of oral EBP11-F4 2.5 mg Receives: Drug: EBP11-F4 |
| Treatment P EBP11-F2 1.5 mg | Experimental | Single dose of oral EBP11-F2 1.5 mg Receives: Drug: EBP11-F2 |
| Treatment Q EBP11-F4 2.5 mg | Experimental | Single dose of oral EBP11-F4 2.5 mg Receives: Drug: EBP11-F4 |
| Treatment R EBP11-F5 3.0 mg | Experimental | Single dose of oral EBP11-F5 3.0 mg Receives: Drug: EBP11-F5 |
| Treatment S EBP11-F1 1.0 mg | Experimental | Single dose of oral EBP11-F1 1.0 mg Receives: Drug: EBP11-F1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the pharmacokinetic profile of plasma hPTH(1-34) after single or twice daily oral administration for treatment regimen as listed under Arms and Interventions at 5, 10, 15, 20, 40, 50, 60, 75, 90, 105, 120, 180, 240, 360 min. post dose
Pharmacokinetic parameter - plasma hPTH(1-34) in pg/mL
Measured: 6 hours
Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen
Pharmacokinetic parameter - total drug exposure at different time points up to 360 min. post dose
Measured: 6 hours
Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen
Pharmacokinetic parameter - total drug exposure in pg/mL over time from 0 extrapolated to infinity
Measured: 6-14 hours
Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen
Pharmacokinetic parameter - Percent of AUC0-inf extrapolated to confirm reliability
Measured: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Cmax for each treatment regimen
Pharmacokinetic parameter - hPTH (1-34) maximal concentration in pg/mL (Cmax)
Measured: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Tmax for each treatment regimen
Pharmacokinetic parameter - time in minutes to reach max. concentration of hPTH(1-34)
Measured: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Kel for each treatment regimen
Pharmacokinetic parameter - elimination rate constant in pg/mL, fraction of drug eliminated per time-point up to 360 min. post dose
Measured: 6 hours
Calculation of plasma levels of hPTH(1-34) t½ for each treatment regimen
Pharmacokinetic parameter - terminal elimination half life of hPTH(1-34) in minutes
Measured: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Tlast for each treatment regimen
Pharmacokinetic parameter - time of the last measurable concentration of hPTH(1-34) in minutes
Measured: 6-14 hours
Assessment of inter-subject variability of hPTH(1-34) for each treatment regimen
Pharmacokinetic parameter - Coefficient of Variance (CV%) of hPTH (1-34)
Measured: 6-14 hours
Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
Pharmacokinetic parameter
Measured: 6 hours
Assessment of the duration of exposure to hPTH(1-34) in minutes
Pharmacokinetic parameter - up to 360 min. post dose
Measured: 6 hours
Vital Signs - body temperature (Celsius)
Safety parameter (group mean at each time point up to 360 min. post dose)
Measured: 6 hours
Vital Signs - respiratory rate (breaths per minute)
Safety parameter (group mean at each time point up to 360 min. post dose)
Measured: 6 hours
Vital Signs - blood pressure (systolic/diastolic mmHg)
Safety parameter (group mean at each time point up to 360 min. post dose)
Measured: 6 hours
Vital Signs - heart rate (beats per minute)
Safety parameter (group mean at each time point up to 360 min. post dose)
Measured: 6 hours
Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator
Safety parameter - AEs observed over duration of study participation
Measured: 6-14 hours
Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator
Safety parameter - SAEs observed over duration of study participation
Measured: 6-14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start11 May 2023
- Primary completion8 Feb 2026
- Study completion8 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Bio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yosef Caraco, MD, Principal investigator, Clinical Research Center Hadassah Ein Kerem Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965167
- Sponsor's protocol ID
- ENT-11-2023
- Status last verified
- Nov 2025
- First submitted
- 8 Jun 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05965167
- Acronym / sponsor ID
- ENT-11-2023
- Conditions
- Hypoparathyroidism, Osteoporosis, Fractures, Bone, Other Disease
- Keywords
- Hypoparathyroidism, PTH(1-34), Parathyroid Hormone, Teriparatide, Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Entera Bio Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 8 Feb 2026 (actual)
- Study completion
- 8 Feb 2026 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| Treatment A EBP05 2.5 mg | Experimental | Drug: EBP05Single dose of oral EBP05 2.5 mg |
| Treatment B EBP05 1.5 mg | Experimental | Drug: EBP05Single dose of oral EBP05 1.5 mg |
| Treatment C Forteo 0.02 mg | Experimental | Drug: Forteo 0.02 mgSingle SC injection of Forteo 0.02 mg |
| Treatment D EBP11 1.5 mg | Experimental | Drug: EBP11Single dose of oral EBP11 1.5 mg |
| Treatment E EBP11 BID (dose determined after IA) | Experimental | Drug: EBP11BID administration of oral EBP11 2.5 mg tablets |
| Treatment F EBP11 BID (dose determined after IA) | Experimental | Drug: EBP11BID 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. |
| Treatment G EBP11 1.5 mg | Experimental | Drug: EBP11Single dose of oral EBP11 1.5 mg |
| Treatment I EBP22 1.5 mg | Experimental | Drug: EBP22Single dose of oral EBP22 1.5 mg |
| Treatment J EBP22 1.5 mg | Experimental | Drug: EBP22Single dose of oral EBP22 1.5 mg |
| Treatment K EBP05 1.5 mg | Experimental | Drug: EBP05Single dose of oral EBP05 1.5 mg |
| Treatment L EBP05 2.5 mg | Experimental | Drug: EBP05Single dose of oral EBP05 2.5 mg |
| Treatment M Forteo 0.02 mg | Experimental | Drug: Forteo 0.02 mgSingle SC injection of Forteo 0.02 mg |
| Treatment N EBP05 3.0 mg | Experimental | Drug: EBP05Single dose of oral EBP05 3.0 mg |
| Treatment H EBP22 2.5 mg (5 x 0.5 mg tablets) | Experimental | Drug: EBP22Single dose of oral EBP22 2.5 mg (5 x 0.5 mg tablets) |
| Treatment O EBP11-F4 2.5 mg | Experimental | Drug: EBP11-F4Single dose of oral EBP11-F4 2.5 mg |
| Treatment P EBP11-F2 1.5 mg | Experimental | Drug: EBP11-F2Single dose of oral EBP11-F2 1.5 mg |
| Treatment Q EBP11-F4 2.5 mg | Experimental | Drug: EBP11-F4Single dose of oral EBP11-F4 2.5 mg |
| Treatment R EBP11-F5 3.0 mg | Experimental | Drug: EBP11-F5Single dose of oral EBP11-F5 3.0 mg |
| Treatment S EBP11-F1 1.0 mg | Experimental | Drug: EBP11-F1Single dose of oral EBP11-F1 1.0 mg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- History or current condition of mental instability or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.
- Active gastrointestinal inflammatory disorder, gastrointestinal motility disorders, and chronic gastritis, including but not limited to: ulcerative colitis, Crohn's disease, irritable bowel syndrome, short bowel syndrome, celiac disease, gastroparesis, that may affect drug bioavailability.
- Any conditions or factors that, in the judgment of the PI or designee, somehow may impact gastrointestinal absorption, distribution or metabolism of parathyroid hormone analogues, or known to potentiate or predispose to undesired effects.
- History of significant gastrointestinal, liver or kidney disease, or gastrointestinal surgery (including bariatric surgery, or any other interventional procedures with stomach and intestinal tract) that may affect either drug bioavailability, or hPTH(1-34) or SNAC metabolism.
- History or presence of alcohol or drug abuse or positive urine drug or blood alcohol results at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBP05Also: hPTH(1-34)Oral tablets | Drug | Treatment A EBP05 2.5 mg, Treatment B EBP05 1.5 mg, Treatment K EBP05 1.5 mg, Treatment L EBP05 2.5 mg, Treatment N EBP05 3.0 mg |
| Forteo 0.02 mgAlso: hPTH(1-34)Subcutaneous injection | Drug | Treatment C Forteo 0.02 mg, Treatment M Forteo 0.02 mg |
| EBP11Also: hPTH(1-34)Oral tablets | Drug | Treatment D EBP11 1.5 mg, Treatment E EBP11 BID (dose determined after IA), Treatment F EBP11 BID (dose determined after IA), Treatment G EBP11 1.5 mg |
| EBP22Also: hPTH(1-34)Oral tablets | Drug | Treatment H EBP22 2.5 mg (5 x 0.5 mg tablets), Treatment I EBP22 1.5 mg, Treatment J EBP22 1.5 mg |
| EBP11-F2Also: hPTH(1-34)Oral tablets | Drug | Treatment P EBP11-F2 1.5 mg |
| EBP11-F4Also: hPTH(1-34)Oral tablets | Drug | Treatment O EBP11-F4 2.5 mg, Treatment Q EBP11-F4 2.5 mg |
| EBP11-F1Also: hPTH(1-34)Oral tablets | Drug | Treatment S EBP11-F1 1.0 mg |
| EBP11-F5Also: hPTH(1-34)Oral tablets | Drug | Treatment R EBP11-F5 3.0 mg |
Primary outcome
Assessment of the pharmacokinetic profile of plasma hPTH(1-34) after single or twice daily oral administration for treatment regimen as listed under Arms and Interventions at 5, 10, 15, 20, 40, 50, 60, 75, 90, 105, 120, 180, 240, 360 min. post dose
Time frame: 6 hours
Pharmacokinetic parameter - plasma hPTH(1-34) in pg/mL
Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen
Time frame: 6 hours
Pharmacokinetic parameter - total drug exposure at different time points up to 360 min. post dose
Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - total drug exposure in pg/mL over time from 0 extrapolated to infinity
Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - Percent of AUC0-inf extrapolated to confirm reliability
Calculation of plasma levels of hPTH(1-34) Cmax for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - hPTH (1-34) maximal concentration in pg/mL (Cmax)
Calculation of plasma levels of hPTH(1-34) Tmax for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - time in minutes to reach max. concentration of hPTH(1-34)
Calculation of plasma levels of hPTH(1-34) Kel for each treatment regimen
Time frame: 6 hours
Pharmacokinetic parameter - elimination rate constant in pg/mL, fraction of drug eliminated per time-point up to 360 min. post dose
Calculation of plasma levels of hPTH(1-34) t½ for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - terminal elimination half life of hPTH(1-34) in minutes
Calculation of plasma levels of hPTH(1-34) Tlast for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - time of the last measurable concentration of hPTH(1-34) in minutes
Assessment of inter-subject variability of hPTH(1-34) for each treatment regimen
Time frame: 6-14 hours
Pharmacokinetic parameter - Coefficient of Variance (CV%) of hPTH (1-34)
Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
Time frame: 6 hours
Pharmacokinetic parameter
Assessment of the duration of exposure to hPTH(1-34) in minutes
Time frame: 6 hours
Pharmacokinetic parameter - up to 360 min. post dose
Vital Signs - body temperature (Celsius)
Time frame: 6 hours
Safety parameter (group mean at each time point up to 360 min. post dose)
Vital Signs - respiratory rate (breaths per minute)
Time frame: 6 hours
Safety parameter (group mean at each time point up to 360 min. post dose)
Vital Signs - blood pressure (systolic/diastolic mmHg)
Time frame: 6 hours
Safety parameter (group mean at each time point up to 360 min. post dose)
Vital Signs - heart rate (beats per minute)
Time frame: 6 hours
Safety parameter (group mean at each time point up to 360 min. post dose)
Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator
Time frame: 6-14 hours
Safety parameter - AEs observed over duration of study participation
Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator
Time frame: 6-14 hours
Safety parameter - SAEs observed over duration of study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yosef Caraco, MD principal investigator
Clinical Research Center Hadassah Ein Kerem Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EBP05, Forteo 0.02 mg and EBP11 in people with Hypoparathyroidism and Osteoporosis, run by Entera Bio Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the pharmacokinetic profile of plasma hPTH(1-34) after single or twice daily oral administration for treatment regimen as listed under Arms and Interventions at 5, 10, 15, 20, 40, 50, 60, 75, 90, 105, 120, 180, 240, 360 min. post dose (time frame: 6 hours). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.