NCT07024407

A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.

Phase 1b Study of Andecaliximab in Participants With Spinal Cord Injury at Risk of Developing Heterotopic Ossification

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ashibio Inc · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study of andecaliximab in participants at risk of developing bone where bone should not be, such as in muscle, tendons, and other soft tissues following traumatic spinal cord injury. The goal of this study is to assess the safety of andecaliximab, how much drug is in the body over time (pharmacokinetics/PK), and how it affects the body (pharmacodynamics/PD) in participants who have had a recent traumatic spinal cord injury.

Detailed description

Safety: To evaluate the safety profile of andecaliximab in participants with spinal cord injurySCI at risk for Heterotopic Ossification. PK: To describe the PK profile of andecaliximab in all participants. Secondary Objective: PD: To describe the PD profile of andecaliximab in all participants.

Conditions

• Heterotopic Ossification (HO)

Interventions

Type	Name	Description
DRUG	Andecaliximab	Participants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study