RecruitingPhase 1ACTRN12625000632493

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

A Phase 1, Multi Dose Study to Evaluate the Safety and Pharmacokinetics of GB-hMG (Menotropins) for Subcutaneous Injection in Healthy Premenopausal Women

Sponsor

Accelagen Pty Ltd

Enrollment

20 participants

Start Date

Jul 11, 2025

Study Type

Interventional

Conditions

Infertility

Summary

This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Up to twenty eligible, healthy volunteers will receive one (1) subcutaneous (SC) injection of 225 international units (IU) per day for seven (7) consecutive days to evaluate the safety, pharmacokinetics, and pharmacodynamics of GB-hMG.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 42 Yearss

Plain Language Summary

Simplified for easier understanding

Fertility treatments for women often use a class of hormones called gonadotropins to stimulate egg production. GB-hMG is a new version of a gonadotropin called human menopausal gonadotropin (hMG), and this study is the first to test multiple daily doses of it in healthy volunteers to understand how the body processes the drug. Before receiving the study medication, participants will undergo a short course of oral contraceptive pills followed by a hormone injection to temporarily suppress their natural hormone cycle. They will then receive one injection of GB-hMG daily for seven days. Blood tests and ultrasound scans will track hormone levels and follicle development throughout the study. This study is open to healthy premenopausal women aged 18 to 42 with regular menstrual cycles and a BMI between 18 and 38. Participants must not be pregnant, planning pregnancy, or breastfeeding. Women with conditions like polycystic ovary syndrome, diabetes, or significant health issues are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Twenty eligible, healthy v

This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Twenty eligible, healthy volunteers will receive one (1) daily subcutaneous (SC) injection of 225 international units (IU) of GB-hMG for seven (7) days. The dose will be administered via SC injection into the abdomen by an appropriately qualified, Good Clinical Practice (GCP)-trained, and experienced member of the study staff. Participants will remain under observation at the CRU for 2 days after administration of study drug and will be discharged only after review by the Investigator (i.e., Study Day 3).