Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)
Status:
Not yet recruiting
Trial end date:
2023-11-15
Target enrollment:
Participant gender:
Summary
SAR439459 is a human anti-TGFβ monoclonal antibody. This phase 1 clinical study investigates
the safety, tolerability, and activity of a single dose of SAR439459 in adult participants
with OI.
Participants will receive a single IV dose of SAR439459 with safety, pharmacokinetic (PK),
and pharmacodynamic (PD) assessments over 24 weeks.
There will be up to 3 dose cohorts. In addition to safety, tolerability, and PK assessments,
bone mineral density (BMD) will be evaluated by dual-energy Xray absorptimetry (DXA) scan and
a series of blood biomarkers will be monitored to document pharmacodynamic effects of the
single dose of SAR439459.