Overview

Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women

Status:
Completed

Trial end date:
2014-08-01

Target enrollment:

Participant gender:

Summary

THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in healthy postmenopausal women. The study is expected to identify a safe dose that can be further tested in subsequent multiple dose studies comparing the safety, PK and pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).

Phase:

Phase 1

Details

Lead Sponsor:

Thar Pharmaceuticals, Inc

Treatments:

Diphosphonates
Zoledronic Acid