drugset / Trial / NCT01721993
Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women
Non-randomizedParallel-groupOpen-labelBasic science
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).
Timeline
- Start
- 2013-01
- Primary completion
- 2014-07
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | T121 | Unknown | — | — |
| Comparator | Zoledronic acid | Other / unclassified | — | Intravenous |
Indications
No indication recorded.