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

Phase 1

Not yet recruiting

• Conditions: Infertility, Female
• Interventions: Drug: QL1012D; Drug: Gonal-F®

• Registration Number: NCT06864793
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-11
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A QL1012D	QL1012D	-
Arm B Gonal-F®	Gonal-F®	-

Primary Outcome Measures

Name	Time	Method
Cmax (maximum plasma concentration)	First Period: From pre-dose (0 hour) to 216 hours post-dose on Day 1. Second Period: From pre-dose (0 hour) to 216 hours post-dose on Day 11	Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects.
AUC (area under the curve)	First Period: From pre-dose (0 hour) to 216 hours post-dose on Day 1. Second Period: From pre-dose (0 hour) to 216 hours post-dose on Day 11	Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D＆Gonal-f® in healthy Chinese female subjects.