Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus

Inclusion Criteria: * Signed and dated informed consent form provided by the subject prior to proceeding with any study-related procedure, * At least 18 years old, * Pregnancy between 12 and 27 weeks gestational age as confirmed by early ultrasound, * Pregnant RhD-negative woman carrying an RhD-positive fetus confirmed by a non-invasive fetal RhD genotyping test, * Negative serology: HIV (1 and 2), hepatitis C and hepatitis B, except for positive results due to vaccinations, * Covered by healthcare insurance in accordance with local requirements. Exclusion Criteria: * RhD allo-immunized subject, * Positive for ADA test, * Multiple fetuses, * Occurrence of a documented potential sensitizing event in this pregnancy before the antenatal IMP administration, * Prior administration of anti-RhD immunoglobulin during the current pregnancy, * Known clinically relevant maternal or fetal abnormality (e.g., as determined by ultrasound or genetic testing), such as placenta previa, * History of anaphylactic or severe systemic reaction to immunoglobulin of any origin, * Current diagnosis of an immune disease which by itself or its treatment could impair the safety and/or efficacy evaluation of Roledumab in this study. These diseases are: All immune deficiencies, particularly those requiring IV-Ig supplementation or other systemic treatment / connective tissue and autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, rheumatoid arthritis, ankylosing spondylarthritis) requiring systemic immunosuppressive treatment / allergic and inflammatory diseases requiring systemic immunosuppressive treatment, * Clinically significant medical history contraindicating the participation in the study according to the judgment of the Investigator or Sponsor, * Clinically significant laboratory (hematology, blood chemistry, or urinalysis) parameters, * For the IM arm only, subject with coagulation disorders contraindicating intramuscular injection (patient will still be considered for the IV arm), * Transfusion of RhD-positive blood or blood derived products within the 6 months prior to enrolment, * Anticipated poor compliance with the study procedures, * Subject within exclusion period further to her participation in a clinical study.