Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)

Exclusion Criteria

• •Previously installed rods or metal hardware that would prevent bone mineral density evaluation of the lumbar spine (note: only two of the L1-L4 vertebrae are necessary for evaluation).
• •History of moderate (25-40°) to severe (\>40°) scoliosis assessed as Cobb angle (unless scoliosis does not impact assessment of bone mineral density in the lumbar vertebrae in the opinion of the investigator).
• •Postmenopausal women who:
• •* Are within 5 years of the onset of menopause (for example less than 5 years from their last menstruation or post-hysterectomy), however if the person has been on hormone replacement therapy for more than 1 year prior to enrollment, then they are eligible regardless of time from onset of menopause. The person must be willing to continue hormone replacement therapy throughout the study duration. OR
• •* Were previously on hormone replacement therapy but have stopped within the past 5 years.
• •History of treatment with denosumab, anti-sclerostin antibody, parathyroid hormone, bisphosphonates, or any other experimental therapy for OI within 6 months prior to any study baseline assessment.
• •Known bleeding disorder.
• •History of significant bleeding event that required hospitalization, surgery, or a blood transfusion that was possibly associated with increased bleeding tendency.
• •Any major surgery within the last 28 days prior to investigational medicinal product (IMP) administration.
• •Elective surgery or invasive procedure anticipated within 6 months after the IMP administration.
• •Therapeutic doses of anticoagulants or antiplatelet agents (eg, 1 mg/kg bid of enoxaparin, 300 mg of aspirin daily, and 75 mg of clopidogrel daily or equivalent) within 7 days prior to the IMP administration.
• •Any known central nervous system (CNS) or intraocular lesion that has a risk of bleeding.
• •Prior history of skin cancers including melanoma, squamous cell carcinoma, or basal cell carcinoma.
• •Clinically significant cardiac valvular disorder or symptomatic heart failure.
• •Vitamin D (25-hydoxyvitamin D) \<15 ng/dL; rescreening will be allowed after supplementation.
• •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.