A Randomized, Open-label, Two-Period, Two-Crossover Study to Compare the Safety and Pharmacokinetics of Recombinant Human Follicle Stimulating Hormone Injection (LM001) and Gonal-F® in Healthy Female Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 主要终点
- Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
研究概览
简要总结
Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®, both given subcutaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide written informed consent.
- •Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
- •Age between 18 to 40 years (inclusive).
- •Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,
- •Regular menstruation cycle (25 to 34 days, inclusive).
- •Normal findings in sex hormone examinations, including FSH, LH, prolactin (PRL), estradiol (E2), progesterone (P), testosterone (T) unless the investigator considers an abnormality to be clinically irrelevant for this study.
排除标准
- •Smoke ≥5 cigarettes or the equivalent per day within 3 months prior to the study
- •History of hypersensitivity to FSH, or hypersensitivity to luteinizing hormone releasing hormone agonist or something like that.
- •Historic abuse of alcoholic beverages and drugs (Drink 14 units of alcohol/week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine.
- •Taken any liver enzyme activity relative drug within 28 days prior to the screening.
- •Take any prescription drug, OTC drug, vitamin product or herbal medicine within 14 days prior to the screening.
- •Taken special diets (including pitaya, mango, grapefruit, etc.) or have strenuous exercise, or something affect the absorption, distribution, metabolism, excretion, etc. of the drug within 2 weeks prior to the study.
- •Major changes in diet or exercise habits recently
- •Participation in a clinical study within 3 months prior to the study.
- •Acute disease or combination therapy from the screening to the beginning time of the study.
- •Take any alcoholic product within 48 hours prior to the study.
- •Take chocolate, any caffeine-containing or xanthine-rich food or drinks within 48 hours prior to using the drug;
- •Blood donation or massive blood losing (>450mL) within 3 months prior to the screening;
- •Viral hepatitis (including hepatitis B and hepatitis C), HIV, and Treponema pallidum positive.
- •History of significant diseases such as circulatory, endocrine, neurological, reproductive, digestive, and respiratory systems, hematology, immunology, psychiatry, and metabolic abnormalities, or past or current medical history that could interfere with the test results, eg subjects with or have suffered from hypothyroidism, adrenocortical insufficiency and hyperprolactinemia, polycystic ovary syndrome, and ovarian dysfunction, premature ovarian failure (POI) or primary ovarian failure, unexplained uterine bleeding, hypothalamic or pituitary tumors, ovarian, uterine or breast cancer, history of thrombosis, history of malignancy;
- •Baseline of serum FSH ≥15 IU/L.
- •History of ovarian hyperstimulation syndrome (OHSS).
- •Other abnormalities judged by researchers of the study
- •Abnormal physical examination and clinical significance judged by researchers of the study
- •Abnormal vital signs and clinical significance judged by researchers of the study.
- •Abnormal laboratory tests with clinically relevance.
- •Abnormal electrocardiogram [ECG] findings.
- •III/IV class endometriosis, submucous myoma of uterus, endocrine abnormalities within 6 months prior to the study.
- •Abnormal imaging examination and clinical significance judged by researchers of the study, such as with a uterine fibroid diameter ≥ 40 mm.
- •Pregnancy or lactation period.
- •Alcohol screening positive.
- •Urine drug screening positive
研究组 & 干预措施
ARM A
Gonal-F®
干预措施: Gonal-F® (Drug)
ARM B
LM001
干预措施: LM001 (Drug)
结局指标
主要结局
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
时间窗: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose.
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001＆Gonal-f® in healthy Chinese female subjects.
时间窗: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001＆Gonal-f® in healthy Chinese female subjects.
次要结局
未报告次要终点