A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorSuzhou Centergene Pharmaceuticals Co.,Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
T-R (Test-Reference drug)
DrugT: 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)
DrugR: Ovidrel®(Referecne drug) T: SJ04 (Test drug) 250 μg of SJ04 or Oviderl®, administered subcutaneously once at two week intervals.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: T-R Group (Test-Reference drug)Experimental treatment 1 intervention
Group B: R-T Group(Reference-Test drug)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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®
Time frame
day 82
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Analysis of equivalence of Cmax of SJ04 and Ovidrel®
Time frame
day 8Secondary outcomes
1
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 \[MedDRA\])
Time frame
day 82
Immunogenicity
antidrug antibodies (ADA) level
Time frame
day 8Sponsors and contacts
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Source ClinicalTrials.gov