Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers

A Randomized, Double-blind, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers

The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.

Inclusion Criteria:

• Female, Age between 18 to 45 years (inclusive).
• Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg.
• With a history of sexual activity
• Regular menstruation cycle (25 to 35 days, inclusive).
• Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
• Reached the standard within the time window after receiving the down-regulated drug.
• Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
• Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.

Exclusion Criteria:

• History of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; History of thrombosis; or other diseases that considered to influence the study by the investigator.
• Unexplained reproductive tract bleeding.
• Thin-layer cytology examination deemed clinically significant by the investigator.
• Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with.
• Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination.
• Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs
• Consume strong coffee or tea daily
• Historic abuse of alcoholic beverages
• Smoke ≥5 cigarettes per day within 3 months prior to the study
• History of drug abuse
• Unsuitable for participation by the investigator.