NCT01406977

Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)

An Open-label, Intra-patient Dose-escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine tolerability, PK/PD and preliminary efficacy of BPS804 in adult patients with HPP treated with multiple escalating doses of BPS804. This study will allow a comparison of several doses of the study drug within the first two weeks after administration and after a longer assessment period for the highest dose level to enable selection of dose ranges to be tested in subsequent studies in the HPP indication.

Detailed description

This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.

Conditions

• Hypophosphatasia

Interventions

Type	Name	Description
DRUG	BPS804

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-08-01
• Last updated: 2022-09-16

Locations

1 site across 1 country: Germany