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

NCT06864793 | Active Not Recruiting Phase 1

• 1 other identifier: QL1012D-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cmax (maximum plasma concentration)

  Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects.

  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

• AUC (area under the curve)

  Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D＆Gonal-f® in healthy Chinese female subjects.

  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

Study Arms (2)

Arm A QL1012D

EXPERIMENTAL

Drug: QL1012D

Arm B Gonal-F®

ACTIVE COMPARATOR

Drug: Gonal-F®

Interventions

QL1012D DRUG

A single Subcutaneous injection, 225IU

Also known as: Follitropin alfa

Arm A QL1012D

Gonal-F® DRUG

A single Subcutaneous injection, 225IU

Also known as: Follitropin alfa

Arm B Gonal-F®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: April 6, 2025
• Primary Completion: February 4, 2026
• Study Completion: April 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)