Safety and Efficacy of YB-1113 in Treatment of POI

B

Bright Cell

Status and phase

Not yet enrolling
Phase 1

Conditions

POI

Treatments

Drug: YB-1113

Study type

Interventional

Funder types

Industry

Identifiers

NCT05494723
YB1113-POI

Details and patient eligibility

About

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).

Enrollment

6 estimated patients

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

6 participants in 2 patient groups

Low-dose
Experimental group
Description:
Low-dose YB-1113
Treatment:
Drug: YB-1113
High-dose
Experimental group
Description:
High-dose YB-1113
Treatment:
Drug: YB-1113

Trial contacts and locations

0

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Central trial contact

Jennifer Wang

Data sourced from clinicaltrials.gov

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