Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
A legfontosabb adatok
- Hol
- Amarillo, Bowling Green, Cary, Conroe, Dallas, Durham, Edinburg, El Paso, Flint, Fort Worth, Gilbert, Houston, Humble, La Mesa, Livonia, Macon, Miami Lakes, Niagara Falls, Ocoee, Omaha, Orchard Park, Palm Harbor, Phoenix, Sacramento, San Francisco, Sarasota, Sayre, Torrance és Tucson (Egyesült Államok)Mind a 29 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Amarillo, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Bowling Green, KentuckyHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Cary, North CarolinaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Conroe, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Dallas, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Durham, North CarolinaHospital not named in the registryContact: Victoria Lacasse, MDToborzás még nem indult
- Edinburg, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- El Paso, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Flint, MichiganHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Fort Worth, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Gilbert, ArizonaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Houston, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Humble, TexasHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- La Mesa, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Livonia, MichiganHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Macon, GeorgiaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Miami Lakes, FloridaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Niagara Falls, New YorkHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Ocoee, FloridaHospital not named in the registryContact: Victoria Lacasse, MDToborzás még nem indult
- Omaha, NebraskaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Orchard Park, New YorkHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Palm Harbor, FloridaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Phoenix, ArizonaHospital not named in the registryContact: Victoria Lacasse, MDToborzás még nem indult
- Sacramento, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- San Francisco, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDToborzás még nem indult
- Sarasota, FloridaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Sayre, PennsylvaniaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Torrance, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
- Tucson, ArizonaHospital not named in the registryContact: Victoria Lacasse, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Yarrow Bioscience, Inc.
- Azonosító
- NCT07682896
- A regiszteradat frissítve
- 2026. október 30.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.