Phase 1b Study of Andecaliximab in Participants With Spinal Cord Injury at Risk of Developing Heterotopic Ossification
Ashibio Inc
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.
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.
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 to 89 years. 2. History of traumatic SCI that occurred a minimum of 10 days prior to first study dose. 3. No significant HO identified by CT as defined in the Imaging Charter and meeting one of the following sets of criteria based on TPBS at end of screening: The Inflammatory Group: Inflammation consistent with developing HO The Early HO Group: The third phase on TPBS shows minimal extraskeletal uptake The Prophylactic High-Risk Group: No findings consistent with increased risk of HO but meets all of the following clinical risk factors for HO: 1. Within 1 mont…
Interventions
- DrugAndecaliximab
Participants will receive weekly subcutaneous injections of andecaliximab during inpatient hospitalization, clinic visit, or self-administration if discharged from the hospital
Location
- Craig HospitalDenver, Colorado