Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30

NCT06778304 | Completed Phase 1 DMC

• 1 other identifier: JZB30ART101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bioequivalence; Healthy Volunteers; Pharmacokinetics; Safety; Immunogenicity

Keywords

JZB30; Pharmacokinetics; Bioequivalence; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• ADA（Anti-Drug Antibodies）

  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).

Study Arms (2)

participants received a single subcutaneous injection of reference drug（Gonal F）

ACTIVE COMPARATOR

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

participants received a single subcutaneous injection of test drug （JZB30）

EXPERIMENTAL

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

Interventions

Gonal F DRUG

The reference formulation is the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed and produced by Merck Serono

Also known as: Recombinant Human Follicle-stimulating Hormone

participants received a single subcutaneous injection of reference drug（Gonal F）

jzb30 DRUG

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.

Also known as: Recombinant Human Follicle-stimulating Hormone

participants received a single subcutaneous injection of test drug （JZB30）

Eligibility Criteria

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

You may qualify if:

• Healthy female participants aged 18-45 years (inclusive).
• Body weight ≥45 kg, and body mass index (BMI) between 18-28 kg/m² (inclusive), where BMI = weight (kg) / height (m)².
• Non-pregnant or non-lactating females.
• Menstrual cycle length between 25-34 days (inclusive).
• Females with a history of sexual activity but no plans for pregnancy.
• Liquid-based/thin-layer cytology examination shows no clinically significant abnormalities.
• Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
• Negative test results for HIV, HBV, HCV, or Treponema pallidum (T-trust).
• 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.
• 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.

You may not qualify if:

• Patients with polycystic ovary syndrome (PCOS).
• 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.
• Individuals with special dietary requirements during hospitalization who cannot adhere to a standardized diet.
• 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.
• Individuals with diminished ovarian reserve.
• Individuals engaged in intense physical activities, such as professional athletes.
• Individuals who have used any prescription drugs or therapeutic medications within 1 week prior to dosing.
• Individuals using hormonal contraceptives (short-term contraceptives within 3 months before screening or long-term contraceptives within 6 months before screening).
• 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.
• 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.
• Individuals with a history of drug abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC, etc.).
• Individuals who consume strong coffee or tea daily.
• Individuals who have donated blood or experienced blood loss ≥400 mL within 3 months.
• Individuals who have participated in any drug clinical trial as a subject within 3 months before this trial.
• Individuals deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• West China Second University Hospital: lead
• Shanghai Jingze Biotechnology Co., Ltd.: collaborator
• Chengdu Jingze pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Chen Z, Yu Q, Feng S, Mo L, Cai L, Du C, Du D, Zou Q. A single-center, randomized, open-label, two-period, crossover, fasted bioequivalence study: comparing recombinant human follicle-stimulating hormone for injection (JZB30) with Gonal-f(R) in healthy Chinese female participants. Front Pharmacol. 2025 Nov 10;16:1678830. doi: 10.3389/fphar.2025.1678830. eCollection 2025.

  PMID: 41293254 DERIVED

MeSH Terms

Interventions

follitropin alfa

Study Officials

• Qin Yu

  National Drug Clinical Trial Institution of West China Second Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 16, 2025
• Study Start: January 4, 2021
• Primary Completion: November 16, 2021
• Study Completion: January 17, 2022
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

CN (1)