Monoclonal Antibody Against Prolactin Receptor: A Randomized Placebo-Controlled Study Evaluating Safety, Tolerability, and Pharmacokinetics of Repeated Subcutaneous Administrations in Postmenopausal Women

In a study published on April 1, 2019, involving 29 healthy postmenopausal women, the monoclonal prolactin receptor antibody BAY 1158061 was evaluated for safety, tolerability, and pharmacokinetics through randomized, placebo-controlled trials. Participants received either a placebo or varying doses of BAY 1158061 (30 mg, 60 mg, or 90 mg) via subcutaneous injections at intervals of either 14 or 28 days. The study concluded that BAY 1158061 was well-tolerated with no significant adverse events compared to the placebo, and pharmacokinetic analysis indicated slow absorption, dose-proportional increases in systemic exposure, and a mean elimination half-life ranging from 9 to 16 days. No significant changes in serum prolactin levels were observed, and the drug showed low immunogenicity. These results suggest that BAY 1158061 is a promising candidate for further development in the treatment of endometriosis and other prolactin-mediated diseases.