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

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 1

Conditions

Infertility, Female

Treatments

Drug: QL1012D

Drug: Gonal-F®

Study type

Interventional

Funder types

Industry

Identifiers

NCT06864793

QL1012D-101

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.