About this trial
Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease
Eligibility criteria
Qualifiers
1. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs/symptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS < 3, and the first onset of TED ocular signs/symptoms (by subject report or medical records) occurred > 12 months prior to first study drug administration.
Disqualifiers
1. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period.
Trial design
Treatments tested in this trial
- NTB003
- NTB003
- NTB003
- NTB003 and Placebo