NCT04980248

Study of ALXN1850 in Participants With Hypophosphatasia (HPP)

A Phase 1, Open-label, Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1850 in Adults With Hypophosphatasia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalating study to assess safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of ALXN1850 when given intravenous (IV) and subcutaneous (SC) to adults with HPP.

Conditions

• Hypophosphatasia

Interventions

Type	Name	Description
BIOLOGICAL	ALXN1850	ALXN1850 will be administered as an IV infusion and via the SC route.

Timeline

• Start date: 2021-09-28
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2021-07-28
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study