Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30

A Randomized, Controlled, Open-label, Two-Period, Double-Crossover, Bioequivalence Clinical Trial: Comparing the Clinical Similarity of Recombinant Human Follicle-Stimulating Hormone JZB30 Injection With the Comparator Drug Gonal-f®

Research Objective: Using the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed by Merck Serono as the reference formulation, and the recombinant human follicle-stimulating hormone injection (code: JZB30) produced by Shanghai Jingze Biotechnology Co., Ltd./Chengdu Jingze Biopharmaceutical Co., Ltd. as the test formulation, a single-center, randomized, open-label, two-period, two-crossover designed bioequivalence study was conducted. The study aimed to evaluate the pharmacokinetic behavior, safety, and immunogenicity of the two formulations in healthy adult female Chinese subjects, providing a reference basis for rational clinical use.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Pharmacokinetics; Bioequivalence; Safety; Immunogenicity
• Intervention / Treatment: Drug: Gonal F; Drug: jzb30

Detailed Description

A total of 48 healthy adult female participants were enrolled. On Day 1 (D1), they received a single subcutaneous injection of either the test drug or the reference drug. After a washout period of 8 to 10 days, the subjects entered the second period starting on Day 11 (D11) for crossover administration. Pharmacokinetic (PK) blood samples were collected at specified time points, and the concentration of follicle-stimulating hormone (FSH) in the biological samples was measured using a validated electrochemiluminescence assay based on the MSD platform. The obtained PK data were used for pharmacokinetic analysis. Clinical safety assessments were conducted throughout the trial.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Second University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy female participants aged 18-45 years (inclusive).
2. Body weight ≥45 kg, and body mass index (BMI) between 18-28 kg/m² (inclusive), where BMI = weight (kg) / height (m)².
3. Non-pregnant or non-lactating females.
4. Menstrual cycle length between 25-34 days (inclusive).
5. Females with a history of sexual activity but no plans for pregnancy.
6. Liquid-based/thin-layer cytology examination shows no clinically significant abnormalities.
7. Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
8. Negative test results for HIV, HBV, HCV, or Treponema pallidum (T-trust).
9. Normal or clinically insignificant findings in medical history, physical examination, laboratory tests, and gynecological examinations (e.g., uterus and bilateral ovaries), as judged by the study physician.
10. Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.

Subjects who do not meet any of the above criteria will not be eligible for participation as volunteers.

Exclusion Criteria:

1. Patients with polycystic ovary syndrome (PCOS).
2. Individuals with a history of FSH allergy, including those who have experienced ovarian hyperstimulation syndrome (OHSS) or are known to be allergic to gonadotropin-releasing hormone agonists (GnRH-a) or their analogs.
3. Individuals with special dietary requirements during hospitalization who cannot adhere to a standardized diet.
4. Individuals with a medical history of ovarian, breast, uterine, hypothalamic, or pituitary diseases deemed clinically significant by the investigator, or a history of thrombosis or current thrombotic disorders.
5. Individuals with diminished ovarian reserve.
6. Individuals engaged in intense physical activities, such as professional athletes.
7. Individuals who have used any prescription drugs or therapeutic medications within 1 week prior to dosing.
8. Individuals using hormonal contraceptives (short-term contraceptives within 3 months before screening or long-term contraceptives within 6 months before screening).
9. Individuals with alcohol abuse (defined as consuming more than 21 standard units of alcohol per week, where 1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) or frequent alcohol consumption within 6 months before screening (defined as consuming more than 14 standard units per week, e.g., 240 mL of beer, 30 mL of 40% spirits, or 100 mL of wine) or alcohol consumption within 24 hours before dosing.
10. Individuals who are heavy smokers (smoking more than 5 cigarettes per day within 3 months before the trial) or cannot comply with the smoking ban during the trial.
11. Individuals with a history of drug abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC, etc.).
12. Individuals who consume strong coffee or tea daily.
13. Individuals who have donated blood or experienced blood loss ≥400 mL within 3 months.
14. Individuals who have participated in any drug clinical trial as a subject within 3 months before this trial.
15. Individuals deemed unsuitable for participation by the investigator.

Exclusion:

Subjects who meet any of the above criteria will not be eligible for participation.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: participants received a single subcutaneous injection of reference drug（Gonal F）; On Day 1 (D1), participants received a single subcutaneous injection of the reference drug (injection site: 3-10 cm around the umbilical area) at a dose of 225 IU.	Drug: Gonal F; The reference formulation is the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed and produced by Merck Serono; Other Names: Recombinant Human Follicle-stimulating Hormone
Experimental: participants received a single subcutaneous injection of test drug （JZB30）; After a washout period of 8 to 10 days, the subjects entered the second period starting on Day 11 (D11) for crossover administration	Drug: jzb30; The test formulation is the recombinant human follicle-stimulating hormone injection (code: JZB30) produced by Shanghai Jingze Biotechnology Co., Ltd./Chengdu Jingze Biopharmaceutical Co., Ltd.; Other Names: Recombinant Human Follicle-stimulating Hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC (area under the curve)	To evaluate the bioequivalence between the test formulation (JZB30) and the reference formulation (Gonal-f®) by comparing their pharmacokinetic parameters, including AUC (area under the curve), Cmax (maximum plasma concentration), and Tmax (time to reach maximum concentration), in healthy adult female subjects.	First Period: From pre-dose (0 hour) to 168 hours post-dose on Day 1 (D1). Second Period: From pre-dose (0 hour) to 168 hours post-dose on Day 11 (D11)
Cmax (maximum plasma concentration)	To evaluate the bioequivalence between the test formulation (JZB30) and the reference formulation (Gonal-f®) by comparing their pharmacokinetic parameters, including AUC (area under the curve), Cmax (maximum plasma concentration), and Tmax (time to reach maximum concentration), in healthy adult female subjects.	First Period: From pre-dose (0 hour) to 168 hours post-dose on Day 1 (D1). Second Period: From pre-dose (0 hour) to 168 hours post-dose on Day 11 (D11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADA（Anti-Drug Antibodies）	To evaluate the immunogenicity of the test formulation (JZB30) and the reference formulation (Gonal-f®) by detecting the presence of anti-drug antibodies (ADA) and assessing their potential impact on pharmacokinetics and safety in healthy adult female subjects.	First Period: Pre-dose (0 hour) and 168 hours post-dose on Day 1 (D1). Second Period: Pre-dose (0 hour) and 168 hours post-dose on Day 11 (D11). Follow-up: Up to 7 days after the last dose in the second period (Day 18).

Collaborators and Investigators

• Sponsor: West China Second University Hospital
• Collaborators: Shanghai Jingze Biotechnology Co., Ltd.; Chengdu Jingze pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Qin Yu, National Drug Clinical Trial Institution of West China Second Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Bioequivalence; Immunogenicity; JZB30
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones; Follicle Stimulating Hormone
• Other Study ID Numbers: JZB30ART101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No