Comparing SJ04 and Ovidrel® in healthy women

A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China

This study is testing a new medication called SJ04 to see if it works the same as the existing drug Ovidrel® in healthy women.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Suzhou Centergene Pharmaceuticals Co.,Ltd. (Industry-sponsored)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06599528 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of SJ04, a biosimilar to Ovidrel®, in healthy female subjects. It is a single-centre, randomized, open-label, single-dose, two-cycle, double-crossover study where participants receive either SJ04 or Ovidrel® via subcutaneous injection. After a washout period, the subjects will switch treatments to assess the similarities in drug absorption and effects. The study aims to ensure that SJ04 is comparable to Ovidrel® in terms of how the body processes the drug.

Who should consider this trial

Good fit: Ideal candidates are healthy women aged 20 to 40 with regular menstrual cycles and specific hormonal levels within normal ranges.

Not a fit: Patients with allergies to the study drugs or those currently using fertility treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accessible and potentially cost-effective alternative to Ovidrel® for women undergoing assisted reproductive technology.

How similar studies have performed: Other studies have shown success with biosimilars in reproductive health, suggesting a promising outlook for SJ04.

Eligibility criteria

Inclusion Criteria:

1. Healthy female subjects aged 20 to 40 years old (including boundary values).
2. Weight not less than 45.0 kg, body mass index within the range of 19.0\~26.0 kg/m2 (including boundary values).
3. Menstrual cycle regularity, or menstrual regularity before taking oral contraceptives (25-34 days, including boundary values).
4. 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.
5. LH levels \<5 IU/L, FSH levels \<4 IU/L at Day -1.

Exclusion Criteria:

1. Allergy or suspected allergy to any component of the experimental drug, control drug, GnRH, GnRH analogs used in this study.
2. Use of any LH preparation, human menopausal gonadotropin (hMG) or human chorionic gonadotropin (hCG) preparation within 3 months prior to screening.
3. 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).
4. Ectopic pregnancy within 3 months prior to screening.
5. Presence of clinically significant acute or chronic infection at screening or enrolment。
6. Presence of localised disease affecting the hypodermic site, or inability to tolerate hypodermic injections。
7. Difficulty in blood collection or inability to tolerate venipuncture, or history of needle or blood sickness.
8. 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 .
9. 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.
10. 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.
11. Positive tests for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis spirochete antibody.
12. History of mental illness, substance abuse, drug dependence, or positive substance abuse screen (morphine, THC, methamphetamine, MDMA, ketamine) on the day of admission.
13. Excessive consumption of tea, coffee or caffeinated beverages in the 3 months prior to screening.
14. 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.
15. 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.
16. 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.
17. History of blood donation or bleeding \>400 ml within 3 months prior to screening.
18. 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.
19. 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.

Where this trial is running

Suzhou, Jiangsu

• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Recruiting)

Conditions Assisted Reproductive Technology; Female Infertility