A Phase 1 Safety and Pharmacokinetics Study of GB-hMG in Healthy Women

Fertility medications containing FSH (follicle-stimulating hormone) and LH (luteinising hormone) are used to stimulate the ovaries during IVF and other fertility treatments. GB-hMG is a new formulation of these hormones produced through a novel manufacturing process, and this is the first study to test it in humans. The goal is to understand how the medication behaves in the body at different doses, whether it is safe, and how it stimulates the ovaries. Thirty healthy premenopausal women will be randomly assigned to one of four dose levels and receive a single injection of GB-hMG after a hormone suppression preparation period. Blood tests and ultrasound scans are performed over several weeks to track hormone levels and ovarian response. Participants are not attempting to conceive and must use effective contraception throughout. You may be eligible if you are a healthy premenopausal woman aged 18 to 42 with regular menstrual cycles, a BMI between 18 and 38, and no history of hormonal or ovarian disorders such as PCOS. You must be willing to take a short course of oral contraceptives and a hormone suppression injection as part of the study preparation. Pregnancy, breastfeeding, and plans to become pregnant during the study are exclusion criteria.