Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Key facts
- Where
- East Melbourne, Melbourne N., and St Leonards, AustraliaSee the 3 sites
- Phase
- Phase 2
Where in Australia
- East Melbourne, VictoriaHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
- Melbourne N., VictoriaHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
- St Leonards, New South WalesHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Yarrow Bioscience, Inc.
- Trial code
- NCT07682896
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Blinded, Placebo-Controlled, Two-Part, Phase 2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of YB-101 in Participants With Graves' Disease
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.
Inclusion: 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: 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.