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

NCT ID: NCT06864793

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-04-30

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A QL1012D

Group Type: EXPERIMENTAL

QL1012D

Intervention Type: DRUG

A single Subcutaneous injection, 225IU

Arm B Gonal-F®

Group Type: ACTIVE_COMPARATOR

Gonal-F®

Intervention Type: DRUG

A single Subcutaneous injection, 225IU

Interventions

QL1012D

A single Subcutaneous injection, 225IU

Intervention Type: DRUG

Gonal-F®

A single Subcutaneous injection, 225IU

Intervention Type: DRUG

Other Intervention Names

Follitropin alfa; Follitropin alfa

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lupeng Jin, Project Manager

Role: CONTACT

lupeng.jin@qilu-pharma.com

0531-55821177

Other Identifiers

QL1012D-101

Identifier Type: -

Identifier Source: org_study_id