AzTrials
AzTrials

BioequivalencePhase 1NCT06778304

Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30

A Phase 1 study testing Gonal F and jzb30 in people with Bioequivalence and Healthy Volunteers, run by West China Second University Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Gonal F and jzb30
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
4 Jan 2021to 17 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • Subjects who meet any of the above criteria will not be eligible for participation.
  • -

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Second University Hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Gonal F, jzb30
Keywords
JZB30, Pharmacokinetics, Bioequivalence, Safety, Immunogenicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gonal FDrug

    Also called Recombinant Human Follicle-stimulating Hormone

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

  • jzb30Drug

    Also called Recombinant Human Follicle-stimulating Hormone

    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.

Study groups in NCT06778304
Study groupRoleWhat they receive
participants received a single subcutaneous injection of reference drug（Gonal F）Active comparatorOn 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.
Receives: Drug: Gonal F
participants received a single subcutaneous injection of test drug （JZB30）ExperimentalAfter a washout period of 8 to 10 days, the subjects entered the second period starting on Day 11 (D11) for crossover administration
Receives: Drug: jzb30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  1. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start4 Jan 2021
  3. Primary completion16 Nov 2021
  4. Study completion17 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06778304
Sponsor's protocol ID
JZB30ART101
Status last verified
Jan 2025
First submitted
30 Dec 2024
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41293254

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gonal F and jzb30 in people with Bioequivalence and Healthy Volunteers, run by West China Second University Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (area under the curve) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06778304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in