Safety and Efficacy of YB-1113 in Treatment of POI
Study Details
Study Description
Brief Summary
This phase 1/2 study is to evaluate the safety and tolerability of YB-1113 administered via intravenous (IV) infusion in the treatment of premature ovarian insufficiency (POI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-dose Low-dose YB-1113 |
Drug: YB-1113
Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)
|
| Experimental: High-dose High-dose YB-1113 |
Drug: YB-1113
Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (AE) [48 weeks]
Reported treatment-related AE and serious adverse events (SAE)
Secondary Outcome Measures
- Blood anti-Müllerian hormone (AMH) level [4, 8, 12, 24, and 48 weeks]
Changes of AMH level from baseline
- Day 3 follicle stimulating hormone (FSH) and estradiol (E2) levels [4, 8, 12, 24, and 48 weeks]
Changes of FSH and E2 from baseline
- Antral follicle counts (AFC) [4, 8, 12, 24, and 48 weeks]
Changes of AFC numbers from baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Females, aged between 18 and 40 years (inclusive), 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-week intervals.
-
AMH levels ≤ 1.0 ng/mL (measured on day 2-5 of the menstrual period).
-
Subjects who are generally healthy by laboratory tests at screening
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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
-
Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period
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Subjects who fully understand the research nature of this study and sign the informed consent
Exclusion Criteria:
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Primary amenorrhea or FSH ≥ 40 IU/L
-
Presence of contraindications to pregnancy
-
POI due to cytotoxic chemotherapy or radiation therapy
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Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation, or a family history of POI
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Subjects who are treated with hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology
-
Washout period less than 3 months for HRT
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Subjects with a history of breast cancer or other estrogen-responsive cancer
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Subjects with existing malignant neoplasm
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Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)
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Subjects with Cushing's disease, untreated or inadequately treated thyroid disease, or hyperprolactinemia
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Clinically active autoimmune condition
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Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
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Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- YB Life Science, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YB1113-POI