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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
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.
This study was previously posted by Mereo BioPharma and was transferred to Ultragenyx in February 2021.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Miramar, Florida, United States
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Würzburg, Germany
Start Date
June 1, 2011
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2012
Last Updated
May 11, 2021
10
ACTUAL participants
BPS804
DRUG
Lead Sponsor
Ultragenyx Pharmaceutical Inc
NCT04152551
NCT05317637
NCT03706482
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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