Not Yet RecruitingPhase 1

Safety and Efficacy of YB-1113 in Treatment of POI

6 participantsStarted 2026-12-09

Plain-language 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).

Who can participate

Age range18 Years – 39 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Incidence of treatment-emergent adverse events (AE)

Timeframe: 52 weeks

Trial details

NCT IDNCT05494723

SponsorBright Cell, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-09

Contact for this trial

Jennifer Wang

949-333-3636 jenniferw@brightcellinc.com

View on ClinicalTrials.gov More POI trials