NCT05494723尚未招募1 期
A Phase 1 Study of the Safety and Efficacy of YB-1113 in Treatment of Premature Ovarian Insufficiency (POI) Via Intravenous Infusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 6
- 主要终点
- Incidence of treatment-emergent adverse events (AE)
研究概览
简要总结
This phase 1 study is to evaluate the safety and tolerability of YB-1113 administered via intravenous (IV) infusion in the treatment of premature ovarian insufficiency (POI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 to <40 years old, who are seeking fertility or preservation of fertility
- •Oligo/Amenorrhea for at least 4 months
- •At least two menopausal FSH levels (≥ 25 IU/L) with 4 to 6 weeks interval.
- •AMH levels ≤ 1.0 ng/mL (measured on day 2-5 of the menstrual period).
- •Subjects who are generally healthy by laboratory tests (normal complete blood count (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening
- •For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies
排除标准
- •1. Primary amenorrhea or FSH ≥ 40 IU/L
- •Presence of contraindications to pregnancy
- •POI due to cytotoxic chemotherapy or radiation therapy
- •Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of POI
- •Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology.
- •Washout period less than 3 months for HRT.
- •Subjects with a history of breast cancer or other estrogen responsive cancer.
- •Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm.
- •Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease
- •Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)
- •Subjects with endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia.
- •Subjects under active management for autoimmune disease.
- •Subjects with intra-uterine devices (IUDs).
- •Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
- •Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
- •Subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent
- •Subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and platelet disorders.
研究组 & 干预措施
Low-dose
Experimental
Low-dose YB-1113
干预措施: YB-1113 (Drug)
High-dose
Experimental
High-dose YB-1113
干预措施: YB-1113 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (AE)
时间窗: 52 weeks
Reported treatment-related AE and serious adverse events (SAE)
次要结局
- Follicle-stimulating hormone (FSH) and estradiol (E2) levels(2, 6, 12, 24, and 52 weeks)
- Antral follicle counts (AFC)(2, 6, 12, 24, and 52 weeks)
- Blood anti-Müllerian hormone (AMH) level(2, 6, 12, 24, and 52 weeks)
研究者
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