drugset
drugset / Trial / NCT05137730

A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults

NCT05137730 ↗

Phase 1 Completed 96 enrolled Takeda Takeda Development Center Americas, Inc. · collab
RandomizedCrossoverOpen-labelOther

Summary

The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the main aim is to assess the dose linearity of the new formulation. Participants will receive 2 doses in Part I and 4 doses in Part II. Participants need to visit their doctor approximately 14 days and 30 days after the last dose of study drug.

Timeline

Start
2021-11-29
Primary completion
2022-04-15
Completion
2022-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Parathyroid Hormone Protein / enzyme biologic 25 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 50 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 75 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 100 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 200 ug Subcutaneous

Indications

No indication recorded.