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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 studied for drug safety and bioavailability. EB613 has completed a Phase 1 clinical trial in healthy subjects and is not approved for any indication.
EB613 targets PTH 1-34, the active N-terminal fragment of parathyroid hormone, which belongs to the hormone target class. Delivering PTH 1-34 orally is the focus of the program, since the peptide is normally administered by injection. The Phase 1 study evaluated the pharmacokinetics and pharmacodynamics of oral PTH (1-34) formulations.
EB613 is developed by Entera Bio Ltd., which trades under the ticker ENTX. The company is the sponsor of the oral PTH (1-34) program, including the completed Phase 1 study of oral PTH (1-34) formulations in healthy subjects.
EB613 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
EB613 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 aged 18 years and older and used an active-controlled design.
Yes. EB613 is also known as oral PTH (1-34) and PTH. These names refer to the same Entera Bio Ltd. program testing an oral formulation of the parathyroid hormone fragment PTH 1-34, so searches for oral PTH (1-34) or PTH lead to the same asset.