drugset / Trial / NCT05987449

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

NCT05987449

Phase 1/2 Recruiting 60 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: * Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors. * Part 2 is a multiple-dose study in pediatric male participants with severe or moderate hemophilia A with or without FVIII inhibitors. The overall aim of the study is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of NXT007.

Timeline

Start
2023-09-21
Primary completion
2033-12-11
Completion
2033-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject NXT007 Unknown Subcutaneous

Indications