Actively Recruiting
A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel4 in Healthy Female Subjects in China
Led by Suzhou Centergene Pharmaceuticals Co.,Ltd. · Updated on 2025-02-10
48
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the pharmacokinetics of SJ04, a biosimilar of Ovidrel4, in healthy Chinese female subjects aged 20 to 40 years. The study evaluates how similar the body processes these two recombinant human chorionic gonadotropin injections when given by subcutaneous injection. It is a randomized, open-label, single-dose, two-cycle, double-crossover trial involving healthy women to assess drug similarity and safety. Participants are randomly assigned to two groups: one receives SJ04 first followed by Ovidrel4 after a two-week washout period, and the other receives Ovidrel4 first followed by SJ04 after the same interval. Each injection is a single subcutaneous dose of 250 1g given once per cycle. The crossover design allows each subject to receive both treatments with a washout period in between. During the study, researchers monitor pharmacokinetic measures such as the area under the plasma concentration curve and peak plasma concentration on day 8 after dosing. They also track adverse events and immune responses. The trial involves screening, drug administration on specified days, and follow-up assessments to evaluate safety and drug behavior. Participation lasts through both cycles including the washout and observation periods.
CONDITIONS
Brief Title
A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy female subjects aged 20 to 40 years old (including boundary values)
- Weight not less than 45.0 kg
- Body mass index within 19.0 to 26.0 kg/m2 (including boundary values)
- Regular menstrual cycles of 25 to 34 days, or regular cycles before oral contraceptive use
- Normal or clinically insignificant hormone levels (FSH, LH, PRL, E2, P, T) 2-3 days after last menstrual period
- LH levels less than 5 IU/L and FSH levels less than 4 IU/L at Day -1
You will not qualify if you...
- Allergy or suspected allergy to any component of SJ04, Ovidrel4, GnRH, or GnRH analogs
- Use of LH, human menopausal gonadotropin, or human chorionic gonadotropin preparations within 3 months before screening
- History or current presence of hypothalamic or pituitary tumors, unexplained ovarian enlargement or cysts, abnormal uterine bleeding of unknown cause, malignant tumors of ovaries, uterus, or breast
- Active thromboembolic diseases or uncontrollable thyroid or adrenal dysfunction
- Endocrine disorders like hyperprolactinemia, polycystic ovary syndrome, ovarian hyperstimulation syndrome, or ovarian dysfunction
- Other malignant tumors or diseases of hypothalamus, pituitary, ovaries, or uterus (except uterine fibroids)
- Ectopic pregnancy within 3 months before screening
- Significant acute or chronic infections at screening
- Localized disease affecting injection site or inability to tolerate injections
- Difficulty with blood collection or history of needle/blood sickness
- Use of prescription medications within 14 days or 5 half-lives, or over-the-counter medications within 7 days or 5 half-lives before screening
- History of serious illness in major organ systems affecting suitability
- Abnormal vital signs, physical exam, lab tests, ECG, cytology, or ultrasound judged clinically significant
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of mental illness, substance abuse, or positive drug screen at admission
- Excessive caffeine consumption in last 3 months
- Alcohol intake over 14 standard units per week in last 3 months or inability to abstain during trial
- Smoking at least 5 cigarettes per day in last 3 months or inability to stop tobacco use during trial
- Participation in another drug or device clinical trial within 28-30 days before screening
- Blood donation or bleeding over 400 ml within 3 months before screening
- Pregnancy, breastfeeding, or planning children during trial or 3 months after
- Withdrawal from previous trials for personal reasons or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive a single subcutaneous injection of either SJ04 or Ovidrel® followed by a crossover to the other drug after a 2-week washout period.
2 dosing visits spaced 2 weeks apart
Trial Site Locations
Total: 1 location
1
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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