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

Recruiting Phase 1 Phase 2 Interventional Study
Heterotopic Ossification (HO)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 89
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
10 (estimated)
Sponsor
Ashibio Inc · Industry
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About This Trial
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 wh…
Trial Locations
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Eligibility Criteria
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 Infl…
Contacts

ashibio ashibio Clinical Study Inquiries

650-360-0036

ASH-HO-201@ashibio.com

CONTACT