Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
A legfontosabb adatok
- Hol
- Las Vegas, Orland Park és Wilmington (Egyesült Államok)Mind a 3 helyszín megnézése
- Fázis
- 1. fázis
Helyszínek itt: Egyesült Államok
- Las Vegas, NevadaHospital not named in the registryContact: Ethyreal BioNo longer taking part
- Orland Park, IllinoisHospital not named in the registryContact: Ethyreal BioRésztvevőt keres
- Wilmington, North CarolinaHospital not named in the registryContact: Ethyreal BioRésztvevőt 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
- Ethyreal Bio, Inc.
- Azonosító
- NCT07885605
- A regiszteradat frissítve
- 2026. október 26.
- Eredeti leírás
The primary objective of study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ETHY-001 in healthy volunteers and participants with Thyroid Eye Disease after single subcutaneous doses.A teljes eredeti leírásKevesebb
A Randomized, Double-Masked, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETHY-001
The primary objective of study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ETHY-001 in healthy volunteers and participants with Thyroid Eye Disease after single subcutaneous doses.
Bevonási feltételek: Parts A and B:; Body mass index of 18 kg/m2 at screening; Agree to comply with all protocol requirements; Able to provide written informed consent; Agree to defined medications and monitoring as instructed by the site; Other protocol-defined inclusion criteria will apply; Part B Only:; Must meet the criteria for moderate-to-severe TED.
Kizáró feltételek: The participant has a history of alcohol or substance abuse within the last 12 months before screening; Use of any investigational drug within 60 days prior to the first injection of study drug; History of treatment with teprotumumab or other anti-IGF-1R monoclonal antibodies; Other protocol-defined exclusion criteria apply; Significant medical conditions or physical findings that may affect participant safety; Known hypersensitivity to monoclonal antibody products and/or subcutaneous injections; Part A and Part B:; Active liver or kidney dysfunction at screening; Blood pressure or ECG abnormalities at screening; Pregnancy of plans for pregnancy; breastfeeding.