NCT01417091COMPLETEDanonymous

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

Sponsor

Source record

Ultragenyx Pharmaceutical Inc

Phase

Source record

PHASE2

Modality

AI-normalized

small molecule

Target

AI-normalized

BPS804

Indication / condition

AI-normalized

Osteogenesis Imperfecta

Intervention

Source record

BPS804

Source & freshness

Source record

NCT ID

NCT01417091

Original source

ClinicalTrials.gov

Source last updated

May 11, 2021

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT01417091

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

Sponsor

Ultragenyx Pharmaceutical Inc

Status

COMPLETED

Phase

PHASE2

Condition raw

Osteogenesis Imperfecta

Condition normalized

Osteogenesis Imperfecta

Modality raw

small molecule

Modality normalized

small molecule

Target raw

BPS804

Target normalized

BPS804

Interventions

BPS804

Public preview

Source record

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.

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Investment-Ready Snapshot

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.

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

Source & freshness

Public preview

Create an account to unlock this report

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

Investment-Ready Snapshot

Provenance

Protocol Description

Outcome Measures

Eligibility

Known Results And Readout Context

Patent And IP Landscape

Contacts