A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of IBI3031 in Participants With Thyroid Eye Disease
This is a multicenter, randomized, double-masked, placebo-controlled, single/multiple-dose-escalation trial conducted in Chinese participants with Thyroid Eye Disease (TED), aiming to evaluate the safety and tolerability of IBI3031 administered via subcutaneous or intravenous injection.
• Written informed consent.
• Aged between 18 and 75 years at screening.
• Weight between 45 kg and 100 kg.
• Moderate-to-severe active TED:
‣ CAS ≥ 3 in the study eye at screening and baseline;
⁃ Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
⁃ ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;
• Exophthalmos ≥ 18 mm in the study eye at baseline. (Only applicable to Stage 2)
• Participants must be clinically and biochemically euthyroid, or have mild hypothyroidism or mild-to-moderate hyperthyroidism at screening.
• Positive for Thyrotrophin Receptor Antibody (TRAb) at screening.
• No prior treatment with antithyroid medications and/or thyroid hormone replacement therapy, or having taken antithyroid medications and/or thyroid hormone replacement therapy on a stable dose for at least 6 weeks prior to the first dose, or having not been treated with antithyroid medications and/or thyroid hormone replacement therapy due to intolerable side effects for at least 6 weeks prior to the first dose.
• Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.