NCT05965167

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-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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2026

Completed
Last Updated

February 17, 2026

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

June 8, 2023

Last Update Submit

February 12, 2026

Conditions

HypoparathyroidismOsteoporosisFractures, BoneOther Disease

Keywords

HypoparathyroidismPTH(1-34)Parathyroid HormoneTeriparatideOsteoporosis

Outcome Measures

Primary Outcomes (18)

  • 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

    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

    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

    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

    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)

    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)

    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

    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

    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

    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)

    6-14 hours

  • Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen

    Pharmacokinetic parameter

    6 hours

  • Assessment of the duration of exposure to hPTH(1-34) in minutes

    Pharmacokinetic parameter - up to 360 min. post dose

    6 hours

  • Vital Signs - body temperature (Celsius)

    Safety parameter (group mean at each time point up to 360 min. post dose)

    6 hours

  • Vital Signs - respiratory rate (breaths per minute)

    Safety parameter (group mean at each time point up to 360 min. post dose)

    6 hours

  • Vital Signs - blood pressure (systolic/diastolic mmHg)

    Safety parameter (group mean at each time point up to 360 min. post dose)

    6 hours

  • Vital Signs - heart rate (beats per minute)

    Safety parameter (group mean at each time point up to 360 min. post dose)

    6 hours

  • Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator

    Safety parameter - AEs observed over duration of study participation

    6-14 hours

  • Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator

    Safety parameter - SAEs observed over duration of study participation

    6-14 hours

Other Outcomes (8)

  • Measurement of plasma soybean trypsin inhibitor, Kunitz type (SBTI) levels (EBP05 only)

    6 hours

  • Measurement of plasma salcaprozate sodium (SNAC) levels (EBP05 only)

    6 hours

  • Measurement of serum calcium (albumin-corrected total calcium) for all treatment regimen

    6 hours

  • +5 more other outcomes

Study Arms (19)

Treatment A EBP05 2.5 mg

EXPERIMENTAL

Single dose of oral EBP05 2.5 mg

Drug: EBP05

Treatment B EBP05 1.5 mg

EXPERIMENTAL

Single dose of oral EBP05 1.5 mg

Drug: EBP05

Treatment C Forteo 0.02 mg

EXPERIMENTAL

Single SC injection of Forteo 0.02 mg

Drug: Forteo 0.02 mg

Treatment D EBP11 1.5 mg

EXPERIMENTAL

Single dose of oral EBP11 1.5 mg

Drug: EBP11

Treatment E EBP11 BID (dose determined after IA)

EXPERIMENTAL

BID administration of oral EBP11 2.5 mg tablets

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.

Drug: EBP11

Treatment G EBP11 1.5 mg

EXPERIMENTAL

Single dose of oral EBP11 1.5 mg

Drug: EBP11

Treatment I EBP22 1.5 mg

EXPERIMENTAL

Single dose of oral EBP22 1.5 mg

Drug: EBP22

Treatment J EBP22 1.5 mg

EXPERIMENTAL

Single dose of oral EBP22 1.5 mg

Drug: EBP22

Treatment K EBP05 1.5 mg

EXPERIMENTAL

Single dose of oral EBP05 1.5 mg

Drug: EBP05

Treatment L EBP05 2.5 mg

EXPERIMENTAL

Single dose of oral EBP05 2.5 mg

Drug: EBP05

Treatment M Forteo 0.02 mg

EXPERIMENTAL

Single SC injection of Forteo 0.02 mg

Drug: Forteo 0.02 mg

Treatment N EBP05 3.0 mg

EXPERIMENTAL

Single dose of oral EBP05 3.0 mg

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)

Drug: EBP22

Treatment O EBP11-F4 2.5 mg

EXPERIMENTAL

Single dose of oral EBP11-F4 2.5 mg

Drug: EBP11-F4

Treatment P EBP11-F2 1.5 mg

EXPERIMENTAL

Single dose of oral EBP11-F2 1.5 mg

Drug: EBP11-F2

Treatment Q EBP11-F4 2.5 mg

EXPERIMENTAL

Single dose of oral EBP11-F4 2.5 mg

Drug: EBP11-F4

Treatment R EBP11-F5 3.0 mg

EXPERIMENTAL

Single dose of oral EBP11-F5 3.0 mg

Drug: EBP11-F5

Treatment S EBP11-F1 1.0 mg

EXPERIMENTAL

Single dose of oral EBP11-F1 1.0 mg

Drug: EBP11-F1

Interventions

EBP11DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment D EBP11 1.5 mgTreatment E EBP11 BID (dose determined after IA)Treatment F EBP11 BID (dose determined after IA)Treatment G EBP11 1.5 mg
EBP22DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment H EBP22 2.5 mg (5 x 0.5 mg tablets)Treatment I EBP22 1.5 mgTreatment J EBP22 1.5 mg
EBP11-F2DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment P EBP11-F2 1.5 mg
EBP11-F4DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment O EBP11-F4 2.5 mgTreatment Q EBP11-F4 2.5 mg
EBP11-F1DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment S EBP11-F1 1.0 mg
EBP11-F5DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment R EBP11-F5 3.0 mg
EBP05DRUG

Oral tablets

Also known as: hPTH(1-34)
Treatment A EBP05 2.5 mgTreatment B EBP05 1.5 mgTreatment K EBP05 1.5 mgTreatment L EBP05 2.5 mgTreatment N EBP05 3.0 mg
Forteo 0.02 mgDRUG

Subcutaneous injection

Also known as: hPTH(1-34)
Treatment C Forteo 0.02 mgTreatment M Forteo 0.02 mg

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center Hadassah Ein Kerem Medical Center

Jerusalem, 91120,, Israel

Location

MeSH Terms

Conditions

HypoparathyroidismOsteoporosisFractures, BoneDisease

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yosef Caraco, MD

    Clinical Research Center Hadassah Ein Kerem Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2023

First Posted

July 28, 2023

Study Start

May 11, 2023

Primary Completion

February 8, 2026

Study Completion

February 8, 2026

Last Updated

February 17, 2026

Record last verified: 2025-11

Locations

IL(1)