A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers and Adults and Adolescents With OI

Inclusion Criteria: Parts A and B: Healthy men and women ≥18 to ≤65 years old. Part C: Male and female adults ≥18 to ≤25 years old and adolescents ≥12 to ≤17 years old with a clinical diagnosis of OI Type I (mild) with a defect in COL1A1 and/or COL1A2, as confirmed by genetic testing. Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial. Exclusion Criteria: Parts A and B: History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1. Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed). Hyper- or hypocalcemia. Known sensitivity to mammalian-derived drug preparations and/or any biologics. Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study. Part C: History of skeletal malignancies or bone metastases at any time. History of any skeletal instrumentation that would interfere with study imaging per investigator. Treatment with any bisphosphonates 3 months prior to screening and teriparatide, denosumab, setrusumab or other anabolic and anti-resorptive medications within 6 months prior to baseline. History of or concomitant uncontrolled diseases such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, Paget's disease, abnormal thyroid function or thyroid disease or other endocrine disorders or conditions that could affect bone metabolism. Hyper- or hypocalcemia. Known sensitivity to mammalian-derived drug preparations and/or any biologics. Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.