CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Blosozumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02109042
NCT02109042Phase 1Completed

A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women

Eli Lilly and Company·interventional·Posted Apr 9, 2014·Updated Jul 16, 2018

In Brief

A Phase 1 clinical trial evaluating Blosozumab for Osteoporosis, Postmenopausal. Completed, enrolled 15 participants across 2 sites.

Detailed Summary

The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected. This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug. There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 9, 2014
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.2 years ago

Interventions

Blosozumabdrug

Administered subcutaneously