Assisted Reproductive TechnologyPhase 1NCT06599528
A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
A Phase 1 study testing T-R (Test-Reference drug) and R-T (Reference-Test drug) in people with Assisted Reproductive Technology and Female Infertility, run by Suzhou Centergene Pharmaceuticals Co.,Ltd. at 1 site in China.
Trial summary
This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproductive Technology, Female Infertility
- What is being tested?
- T-R (Test-Reference drug) and R-T (Reference-Test drug)
- 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
- 12 Aug 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects aged 20 to 40 years old (including boundary values).
- Weight not less than 45.0 kg, body mass index within the range of 19.0~26.0 kg/m2 (including boundary values).
- Menstrual cycle regularity, or menstrual regularity before taking oral contraceptives (25-34 days, including boundary values).
- The levels of follicle stimulating hormone(FSH), luteinizing hormone(LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T) detected within 2-3 days after the last menstrual period before the first administration are within normal ranges or considered abnormal by the researchers to have no clinical significance.
- LH levels \<5 IU/L, FSH levels \<4 IU/L at Day -1.
Who cannot join
- Allergy or suspected allergy to any component of the experimental drug, control drug, GnRH, GnRH analogs used in this study.
- Use of any LH preparation, human menopausal gonadotropin (hMG) or human chorionic gonadotropin (hCG) preparation within 3 months prior to screening.
- Previously or currently suffering from the following diseases: hypothalamic or pituitary tumors, unexplained ovarian enlargement or cyst, Abnormal uterine bleeding of unknown etiology, malignant tumors of the ovaries, uterus, or breast, active thromboembolic diseases, uncontrollable thyroid or adrenal dysfunction, endocrine disorders such as hyperprolactinemia, polycystic ovary syndrome, ovarian hyperstimulation syndrome (OHSS), and ovarian dysfunction, other malignant tumors or diseases of the hypothalamus, pituitary gland, ovaries, and uterus (excluding uterine fibroids).
- Ectopic pregnancy within 3 months prior to screening.
- Presence of clinically significant acute or chronic infection at screening or enrolment。
- Presence of localised disease affecting the hypodermic site, or inability to tolerate hypodermic injections。
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- Difficulty in blood collection or inability to tolerate venipuncture, or history of needle or blood sickness.
- Prescription medications taken within 14 days or 5 half-lives prior to screening or over-the-counter medications (including proprietary and herbal medications) taken within 7 days or 5 half-lives prior to screening .
- A history of chronic or serious illness or disease of the liver, kidneys, gastrointestinal tract, endocrine system, cardiovascular, neurological, metabolic, haematological, respiratory, or autoimmune systems or an existing disease of one of the above systems which, in the judgement of the investigator, makes him or her unsuitable for enrolment.
- Abnormalities in vital signs, physical examination, laboratory tests (routine blood, blood biochemistry, urinalysis, coagulation, thyroid function), 12-lead electrocardiogram, liquid-based thin-layer cytometry (TCT), and ultrasound are judged by the investigator to be clinically significant and to warrant participation in the trial.
- Positive tests for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis spirochete antibody.
- History of mental illness, substance abuse, drug dependence, or positive substance abuse screen (morphine, THC, methamphetamine, MDMA, ketamine) on the day of admission.
- Excessive consumption of tea, coffee or caffeinated beverages in the 3 months prior to screening.
- Drinking an average of more than 14 standard units of alcohol per week in the three months prior to screening, or inability to abstain from alcohol during the test period, or a positive breathalyser test result on the day of admission.
- Smoke at least 5 cigarettes per day in the 3 months prior to screening or not be able to stop using any tobacco-based products during the trial.
- Participated in a clinical trial of another drug within 28 days prior to screening and used the test drug, or participated in a clinical trial of a medical device within 1 month prior to screening.
- History of blood donation or bleeding \>400 ml within 3 months prior to screening.
- During pregnancy or breastfeeding, or a positive pregnancy test result. The subject (or his/her partner) is planning to have children (including sperm and egg donation) throughout the trial period and for 3 months after the end of the trial. Unwilling to use one or more non-pharmacological contraceptive methods (e.g. total abstinence, condoms, ligation, etc.) during the trial period.
- Subjects who withdrew from the trial for their own reasons and who, in the opinion of the investigator, were otherwise unsuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Yanxia Yu, 0086-15051404960, yuyxsz@163.com
Yanxia Yu, Doctor
About this study
Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China
This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle, and cross-administered after a washout period.
Read the detailed description
SJ04 is a biosimilar of Ovidrel® and is highly similar to Ovidrel®. The purpose of this study was to evaluate the similarity of pharmacokinetics (PK) between recombinant human chorionic gonadotropin injection (SJ04) and Ovidrel® after administration by a single subcutaneous injection in healthy Chinese female subjects.
Forty-eight screened healthy female subjects were randomly divided into 2 groups, the T-R group and the R-T group, with 24 subjects in each group. On the morning of the day of administration, they received SJ04 injection or Ovidrel® single subcutaneous injection according to the randomisation table, both at a dose of 250 μg, once per cycle, and crossed over after a washout period.
- Being tested
- T-R (Test-Reference drug), R-T (Reference-Test drug)
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-R (Test-Reference drug)Drug
T: SJ04 (Test drug) R: Ovidrel® (Referecne drug) 250 μg of SJ04 injection or Oviderl®, administered subcutaneously once at two week intervals.
R-T (Reference-Test drug)Drug
R: Ovidrel®(Referecne drug) T: SJ04 (Test drug) 250 μg of SJ04 or Oviderl®, administered subcutaneously once at two week intervals.
| Study group | Role | What they receive |
|---|---|---|
| T-R Group (Test-Reference drug) | Experimental | SJ04 is injected first and Ovidrel® is injected after 2-week period Receives: Drug: T-R (Test-Reference drug) |
| R-T Group(Reference-Test drug) | Experimental | Ovidrel® is injected first and SJ04 is injected after 2-week period Receives: Drug: R-T (Reference-Test drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity of SJ04 and Ovidrel®
Measured: day 8
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Analysis of equivalence of Cmax of SJ04 and Ovidrel®
Measured: day 8
Secondary outcomes (2)
Adverse events
The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities [MedDRA])
Measured: day 8
Immunogenicity
antidrug antibodies (ADA) level
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Aug 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Centergene Pharmaceuticals Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599528
- Sponsor's protocol ID
- SZSJ-SJ04-001
- Status last verified
- Feb 2025
- First submitted
- 13 Sep 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China
- ClinicalTrials.gov ID
- NCT06599528
- Acronym / sponsor ID
- SZSJ-SJ04-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Suzhou Centergene Pharmaceuticals Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle, and cross-administered after a washout period.
Detailed description
SJ04 is a biosimilar of Ovidrel® and is highly similar to Ovidrel®. The purpose of this study was to evaluate the similarity of pharmacokinetics (PK) between recombinant human chorionic gonadotropin injection (SJ04) and Ovidrel® after administration by a single subcutaneous injection in healthy Chinese female subjects.
Forty-eight screened healthy female subjects were randomly divided into 2 groups, the T-R group and the R-T group, with 24 subjects in each group. On the morning of the day of administration, they received SJ04 injection or Ovidrel® single subcutaneous injection according to the randomisation table, both at a dose of 250 μg, once per cycle, and crossed over after a washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-R Group (Test-Reference drug) | Experimental | Drug: T-R (Test-Reference drug)SJ04 is injected first and Ovidrel® is injected after 2-week period |
| R-T Group(Reference-Test drug) | Experimental | Drug: R-T (Reference-Test drug)Ovidrel® is injected first and SJ04 is injected after 2-week period |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy female subjects aged 20 to 40 years old (including boundary values).
- Weight not less than 45.0 kg, body mass index within the range of 19.0~26.0 kg/m2 (including boundary values).
- Menstrual cycle regularity, or menstrual regularity before taking oral contraceptives (25-34 days, including boundary values).
- The levels of follicle stimulating hormone(FSH), luteinizing hormone(LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T) detected within 2-3 days after the last menstrual period before the first administration are within normal ranges or considered abnormal by the researchers to have no clinical significance.
- LH levels \<5 IU/L, FSH levels \<4 IU/L at Day -1.
Key exclusion criteria (19 listed)
- Allergy or suspected allergy to any component of the experimental drug, control drug, GnRH, GnRH analogs used in this study.
- Use of any LH preparation, human menopausal gonadotropin (hMG) or human chorionic gonadotropin (hCG) preparation within 3 months prior to screening.
- Previously or currently suffering from the following diseases: hypothalamic or pituitary tumors, unexplained ovarian enlargement or cyst, Abnormal uterine bleeding of unknown etiology, malignant tumors of the ovaries, uterus, or breast, active thromboembolic diseases, uncontrollable thyroid or adrenal dysfunction, endocrine disorders such as hyperprolactinemia, polycystic ovary syndrome, ovarian hyperstimulation syndrome (OHSS), and ovarian dysfunction, other malignant tumors or diseases of the hypothalamus, pituitary gland, ovaries, and uterus (excluding uterine fibroids).
- Ectopic pregnancy within 3 months prior to screening.
- Presence of clinically significant acute or chronic infection at screening or enrolment。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-R (Test-Reference drug)T: SJ04 (Test drug) R: Ovidrel® (Referecne drug) 250 μg of SJ04 injection or Oviderl®, administered subcutaneously once at two week intervals. | Drug | T-R Group (Test-Reference drug) |
| R-T (Reference-Test drug)R: Ovidrel®(Referecne drug) T: SJ04 (Test drug) 250 μg of SJ04 or Oviderl®, administered subcutaneously once at two week intervals. | Drug | R-T Group(Reference-Test drug) |
Primary outcome
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Time frame: day 8
Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity of SJ04 and Ovidrel®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Time frame: day 8
Analysis of equivalence of Cmax of SJ04 and Ovidrel®
2 secondary outcomes
Adverse events
Time frame: day 8
Immunogenicity
Time frame: day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T-R (Test-Reference drug) and R-T (Reference-Test drug) in people with Assisted Reproductive Technology and Female Infertility, run by Suzhou Centergene Pharmaceuticals Co.,Ltd. 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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 10 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) (time frame: day 8). 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?
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 10 Feb 2025.