A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects

NCT06599528 | Recruiting Phase 1

• 1 other identifier: SZSJ-SJ04-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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, and cross-administered after a washout period.

Conditions

Assisted Reproductive Technology; Female Infertility

Outcome Measures

Primary Outcomes (2)

• 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®

  day 8

• Pharmacokinetics: Peak Plasma Concentration (Cmax)

  Analysis of equivalence of Cmax of SJ04 and Ovidrel®

  day 8

Secondary Outcomes (2)

• Adverse events

  day 8

• Immunogenicity

  day 8

Study Arms (2)

T-R Group (Test-Reference drug)

EXPERIMENTAL

SJ04 is injected first and Ovidrel® is injected after 2-week period

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

Drug: R-T (Reference-Test drug)

Interventions

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.

T-R Group (Test-Reference drug)

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.

R-T Group(Reference-Test drug)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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。
• 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.

Sponsors & Collaborators

• Suzhou Centergene Pharmaceuticals Co.,Ltd.: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (1)