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Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

Official title:
A Randomized, Open Label Intra-patient Dose Escalation Study With an Untreated Reference Group to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Infusions of BPS804 in Adults With Moderate Osteogenesis Imperfecta

Clinical Trial Summary

This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI). Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.

Clinical Trial Description

This study was previously posted by Mereo BioPharma and was transferred to Ultragenyx in February 2021. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01417091
Study type Interventional
Source Ultragenyx Pharmaceutical Inc
Contact
Status Completed
Phase Phase 2
Start date June 2011
Completion date December 2012
View Details
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