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Also known as Oral PTH (1-34), PTH
EB613 (oral PTH 1-34) · 1 trial · 1 indication
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile
| Arm | Type | Description |
|---|---|---|
| Active Comparator | ACTIVE_COMPARATOR | Subcutaneous injection of Teriparatide |
| Oral PTH (1-34) | EXPERIMENTAL | Oral administration of pill with API with different optimizations |
| Name | Type | Description |
|---|---|---|
| Teriparatide | DRUG | subcutaneous standard injection |
| Oral PTH (1-34) | DRUG | Different optimization of API |
Inclusion Criteria: 1. Signed Informed consent to the study. 2. Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive, 3. Subjects able to adhere to the visit schedule and protocol requirements 4. Hematology ,Chemistry and Urinalysis values with no clinical significance or do not reflect a medical ...
EB613 is an oral formulation of PTH 1-34, a parathyroid hormone fragment, developed by Entera Bio Ltd. It is an investigational small molecule designed to deliver PTH 1-34 by mouth rather than by injection. The program has completed a Phase 1 study in healthy male subjects.
EB613 targets PTH 1-34, the active N-terminal fragment of parathyroid hormone, which belongs to the hormone class. By delivering this hormone orally, the formulation aims to reproduce the pharmacological action of PTH 1-34, which is normally administered as an injectable peptide.
EB613 is being developed by Entera Bio Ltd., a clinical-stage biopharmaceutical company. Entera Bio trades on the Nasdaq under the ticker symbol ENTX. The company is responsible for the oral PTH 1-34 program.
EB613 (oral PTH 1-34) is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The completed Phase 1 trial evaluated safety, pharmacokinetics, and pharmacodynamics in healthy volunteers.
EB613 (oral PTH 1-34) has been studied in one completed Phase 1 trial, NCT02571140, titled "A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects." The trial enrolled 30 healthy male volunteers and was active-controlled.
Yes, EB613 is also known as oral PTH (1-34) or simply PTH. These names refer to the same investigational oral formulation of the parathyroid hormone fragment developed by Entera Bio Ltd. under the ticker ENTX.