Safety and Efficacy of YB-1113 in Treatment of POI

ConditionPOI

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18-39

SponsorBright Cell, Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

YB-1113

Treatment groups

6 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Bright Cell, Inc.

Lead sponsor

Source ClinicalTrials.gov