Minghui Pharmaceutical (Hangzhou) Ltd
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.
Inclusion Criteria: 1. Body weight ≤ 120 kg. 2. Clinical diagnosis of chronic TED with documented medical evidence of symptoms and signs in the study eye for more than 12 months and less than 10 years prior to study screening. 3. Clinical diagnosis of moderate-to-severe TED at screening and baseline. 4. Do not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study. 5. Diabetic participants must have well-controlled stable disease. Exclusion Criteria: 1. Participants who have: a compressive optic neuropathy of TED…
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
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