A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects

Condition(s) targeted: Drug Safety

Intervention: Teriparatide (Drug); Teriparatide (Drug); placebo (Drug)

Phase: Phase 1

Status: Enrolling by invitation

Sponsored by: Entera Bio Ltd.

Official(s) and/or principal investigator(s):
Yosef Caraco, MD, Principal Investigator, Affiliation: Hadassah Ein Kerem Medical Center

A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety, tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of

Entera's oral PTH(1 - 34) in adult healthy human volunteers.

Official title: A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Adverse events

Detailed description: This study will have three stages. Stage 1: Safety and initial bioavailability of Entera's oral EP101 in adult male healthy volunteers. (SA-BA) Stage 2: Assessment of bioavailability and safety of Entera's oral EP101 in adult male healthy volunteers. (SA-BA-PK-PD) Stage 3:

Safety, PK, and PD of final dose of Entera's oral PTH(1 - 34) in adult healthy male and

female volunteers. (SA-BA-PK-PD)

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ● Signed Informed consent to the study.

- Male and female volunteers ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive,

- Subjects able to adhere to the visit schedule and protocol requirements

- Hematology ,Chemistry and Urinalysis values with no clinical significance or do

not reflect a medical condition which according to the physicians' judgment might confound the results of the study or pose additional risk to the subject by participation in the study.

- Hemoglobin level >. 12. 5 g/dl

- Blood pressure levels with no clinical significance.

- Negative serology to HIV, Hepatitis B, Hepatitis C.

- No known drug and alcohol abuse

- Negative urinary drugs of abuse at screening

- No allergy to soy bean products.

- No prescription medications taken within one month to enrollment

- Over-the-counter drugs (including vitamins) taken within 14 days prior to visit

2 are subject to the investigators' discretion for inclusion.

- No subjects with previous urolithiasis.

- Non-smoking,

- In good health as determined by past medical history, physical examination,

vital signs, electrocardiogram and laboratory tests at screening Exclusion Criteria:

- ● Concurrent therapy that, in the Investigator's opinion, would interfere with the

evaluation of the safety or efficacy of the study medication.

- Treatment with any investigational product within the last 30 days, enrollment

or intention to enroll in any active study involving the use of investigational devices or drugs.

- Presence of any other condition or circumstance that, in the judgment of the

Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.

- Active infections

- History of drug or alcohol abuse

- Known allergies or sensitivities to components of study treatment or study

procedures, including Soy.

- Clinically diagnosed psychiatric disorders that may interfere with patient study

participation

- Medical history known or suspected to increase risks of AEs related to study

drug, up to the investigator's discretion

- Chronic illnesses, up to the investigator's discretion

- Female subjects must have a negative serum pregnancy test at screening and be

willing and able to use a medically acceptable method of birth control (non-hormonal intrauterine device with condom, or diaphragm with condom, or condom with spermicide) from the screening visit through the study termination visit or declare that they are abstaining from sexual intercourse from the screening visit through the study termination visit or are surgically sterile (have undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.

HMO Clinical Research Center Hadassah Ein Kerem Medical Center, Jerusalem 91120,, Israel

Starting date: July 2011
Last updated: August 4, 2015