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drugset / Trial / NCT03516773

Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism

NCT03516773 ↗

Phase 2 Completed 20 enrolled Entera Bio Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

A Randomized, active comparator, two-part, partial crossover design. The study is designed to assess the pharmacokinetics and pharmacodynamics of EnteraBio's Oral PTH(1-34) \[EB612 (EBP05)\] in adult patients with hypoparathyroidism.

Timeline

Start
2018-06-17
Primary completion
2018-12-05
Completion
2019-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject EB612 (EBP05) Unknown 0.75 mg Oral
Subject EB612 (EBP05) Unknown 2.25 mg Oral
Comparator Parathyroid Hormone Protein / enzyme biologic 100 ug Subcutaneous

Indications

hypoparathyroidism