Safety and Efficacy of YB-1113 in Treatment of POI

NCT05494723 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: YB1113-POI
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

POI

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (AE)

  Reported treatment-related AE and serious adverse events (SAE)

  52 weeks

Secondary Outcomes (3)

• Blood anti-Müllerian hormone (AMH) level

  2, 6, 12, 24, and 52 weeks

• 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

Study Arms (2)

Low-dose

EXPERIMENTAL

Low-dose YB-1113

Drug: YB-1113

High-dose

EXPERIMENTAL

High-dose YB-1113

Drug: YB-1113

Interventions

YB-1113 DRUG

Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)

High-dose; Low-dose

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Bright Cell, Inc.: lead

Central Study Contacts

Jennifer Wang

CONTACT

949-333-3636; jenniferw@brightcellinc.com

Study Design

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

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 10, 2022
• Study Start (Estimated): December 9, 2026
• Primary Completion (Estimated): January 9, 2028
• Study Completion (Estimated): April 9, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share