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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
10
Participants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital
Craig Hospital
Denver, Colorado, United States
RECRUITINGTo evaluate the safety of andecaliximab in participants with SCI at risk for HO
Incidence and severity of all serious adverse events (SAEs) and all treatment-emergent adverse events (TEAEs)
Time frame: From signing of the informed consent form until the end of the Safety Follow-up Period (4 weeks after week 9 or Early Termination)
To describe the PK profile of andecaliximab in all participants
PK parameters (area under the time-concentration curve \[AUC\], maximum concentration \[Cmax\],
Time frame: From baseline (Week 1) through Week 9 or Early Termination
To describe the PK profile of andecaliximab in all participants
PK concentration at steady state \[Ctrough\]) describing the profile of andecaliximab
Time frame: From baseline (Week 1) through Week 9 or Early Termination
To describe the PD profile of andecaliximab in all participants
Andecaliximab MMP9 target coverage in plasma over time
Time frame: From baseline (Week 1) through Week 9 or Early Termination
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