A Phase 1 interventional study of EBP05 and Forteo 0.02 mg in Hypoparathyroidism, Osteoporosis and Fractures, Bone, sponsored by Entera Bio Ltd.. Completed at 1 site in Israel. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Entera Bio Ltd. · Phase 1, Interventional, and Treatment
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.
Stated in summary, eligibility criteria and outcome measures
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Entera Bio Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History or presence of :
Subjects with findings deemed abnormal with clinical significance by the PI or designee at screening for the following:
Unable to refrain from or anticipates the use of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of oral EBP05 2.5 mg
Drug: EBP05
Single dose of oral EBP05 1.5 mg
Drug: EBP05
Single SC injection of Forteo 0.02 mg
Drug: Forteo 0.02 mg
Single dose of oral EBP11 1.5 mg
Drug: EBP11
BID administration of oral EBP11 2.5 mg tablets
Drug: EBP11
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.
Drug: EBP11
Single dose of oral EBP11 1.5 mg
Drug: EBP11
Single dose of oral EBP22 1.5 mg
Drug: EBP22
Single dose of oral EBP22 1.5 mg
Drug: EBP22
Single dose of oral EBP05 1.5 mg
Drug: EBP05
Single dose of oral EBP05 2.5 mg
Drug: EBP05
Single SC injection of Forteo 0.02 mg
Drug: Forteo 0.02 mg
Single dose of oral EBP05 3.0 mg
Drug: EBP05
Single dose of oral EBP22 2.5 mg (5 x 0.5 mg tablets)
Drug: EBP22
Single dose of oral EBP11-F4 2.5 mg
Drug: EBP11-F4
Single dose of oral EBP11-F2 1.5 mg
Drug: EBP11-F2
Single dose of oral EBP11-F4 2.5 mg
Drug: EBP11-F4
Single dose of oral EBP11-F5 3.0 mg
Drug: EBP11-F5
Single dose of oral EBP11-F1 1.0 mg
Drug: EBP11-F1
Oral tablets
Also known as: hPTH(1-34)
Subcutaneous injection
Also known as: hPTH(1-34)
Oral tablets
Also known as: hPTH(1-34)
Oral tablets
Also known as: hPTH(1-34)
Oral tablets
Also known as: hPTH(1-34)
Oral tablets
Also known as: hPTH(1-34)
Oral tablets
Also known as: hPTH(1-34)
Oral tablets
Also known as: hPTH(1-34)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 6-14 hours
Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
Pharmacokinetic parameter
Time frame: 6 hours
Assessment of the duration of exposure to hPTH(1-34) in minutes
Pharmacokinetic parameter - up to 360 min. post dose
Time frame: 6 hours
Vital Signs - body temperature (Celsius)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Vital Signs - respiratory rate (breaths per minute)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Vital Signs - blood pressure (systolic/diastolic mmHg)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Vital Signs - heart rate (beats per minute)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator
Safety parameter - AEs observed over duration of study participation
Time frame: 6-14 hours
Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator
Safety parameter - SAEs observed over duration of study participation
Time frame: 6-14 hours
Measurement of plasma soybean trypsin inhibitor, Kunitz type (SBTI) levels (EBP05 only)
Pharmacokinetic parameter in ng/mL
Time frame: 6 hours
Measurement of plasma salcaprozate sodium (SNAC) levels (EBP05 only)
Pharmacokinetic parameter in μg/mL
Time frame: 6 hours
Measurement of serum calcium (albumin-corrected total calcium) for all treatment regimen
Pharmacodynamic parameter in mg/dL at 120, 240, 360 min post dose
Time frame: 6 hours
Measurement of serum phosphate for all treatment regimen
Pharmacodynamic parameter in mg/dL at 120, 240, 360 min post dose
Time frame: 6 hours
Measurement of serum intact hPTH(1-84) for all treatment regimen
Pharmacodynamic parameter in pg/mL at 120, 240, 360 min post dose
Time frame: 6 hours
Measurement of serum 1,25-(OH)2D for all treatment regimen (optional)
Pharmacodynamic parameter in ng/mL at 120, 240, 360 min post dose
Time frame: 6 hours
Assessment of food effect on EBP05 PK profile
Pharmacokinetic parameter measured in pg/mL
Time frame: 60 minutes
Assessment of food effect on EBP11 PK profile
Pharmacokinetic parameter measured in pg/mL
Time frame: 60 minutes
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Teriparatide
Entera Bio Ltd.