Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease

Purpose

This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body. The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2. Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.

Condition

  • Graves' Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have a documented diagnosis of Graves' Disease confirmed by the presence of thyroid-stimulating hormone receptor antibodies (TRAbs) by medical history or screening laboratory assessment - Have a pre-existing diagnosis of TED or, conversely, no evidence of TED at the ophthalmological examination performed during screening - Additional inclusion criteria are defined in the protocol

Exclusion Criteria

  • Previously treated with radioactive iodine (RAI) therapy or underwent total thyroidectomy - Received any dose of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening - Current treatment with teprotumumab or exposure to teprotumumab within 15 weeks prior to screening - History of hyperthyroidism not caused by Graves' disease (eg. toxic adenoma, or toxic multinodular goiter) within 6 months before the screening visit - Pregnant or lactating women - Additional exclusion criteria are defined in the protocol

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
YB-101 		In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
  • Drug: Experimental: YB-101
    YB-101 is administered over a 24 week period.
  • Drug: Placebo YB-101
    Placebo will be administered over a 24 week period.
Placebo Comparator
Placebo YB-101 		In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.
  • Drug: Placebo YB-101
    Placebo will be administered over a 24 week period.

Recruiting Locations

Site 107
Livonia, Michigan 48152

Site 100
Amarillo, Texas 79124

Site 117
Conroe, Texas 77384

Site 101
Humble, Texas 77346

More Details

Status
Recruiting
Sponsor
Yarrow Bioscience, Inc.

Study Contact

Victoria Lacasse, MD
469-278-6161
VL@YarrowBioscience.com