NCT01417091

Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Osteogenesis Imperfecta

Interventions

Type	Name	Description
DRUG	BPS804

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-08-16
• Last updated: 2021-05-11

Locations

6 sites across 4 countries: United States, Belgium, Canada, Germany