Clinical trial NCT06864793: Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Infertility, Female
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Cmax (maximum plasma concentration)
timeFrame: 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
measure: AUC (area under the curve)
timeFrame: 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
Secondary outcomes:
Other outcomes:
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Study officials:
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