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

Inclusion Criteria:

• Participants who are clinically categorized as Type I or IV osteogenesis imperfectawith a previously documented pathogenic genetic variant in human collagen type 1alpha 1 gene (COL1A1) or human collagen type 1 alpha 2 gene (COL1A2).

• Participants who have experienced at least 1 bone fracture in the past 10 years OR 2or more (≥2) fractures since the age of 18.

• Body weight ≥30.0 kg.

• Contraception for sexually active male participants or female patient; not pregnantor breastfeeding; no sperm donating for male participant.

• Signed written informed assent/consent.

Exclusion Criteria:

• Previously installed rods or metal hardware that would prevent bone mineral densityevaluation of the lumbar spine (note: only two of the L1-L4 vertebrae are necessaryfor 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 lumbarvertebrae in the opinion of the investigator).

• Postmenopausal women who:

• Are within 5 years of the onset of menopause (for example less than 5 yearsfrom their last menstruation or post-hysterectomy), however if the person hasbeen on hormone replacement therapy for more than 1 year prior to enrollment,then they are eligible regardless of time from onset of menopause. The personmust be willing to continue hormone replacement therapy throughout the studyduration. 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 toany study baseline assessment.

• Known bleeding disorder.

• History of significant bleeding event that required hospitalization, surgery, or ablood 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 IMPadministration.

• Therapeutic doses of anticoagulants or antiplatelet agents (eg, 1 mg/kg bid ofenoxaparin, 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 ofbleeding.

• Prior history of skin cancers including melanoma, squamous cell carcinoma, or basalcell carcinoma.

• Clinically significant cardiac valvular disorder or symptomatic heart failure.

• Vitamin D (25-hydoxyvitamin D) <15 ng/dL; rescreening will be allowed aftersupplementation.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.