[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTT11 in healthy subjects and patients with moderate to severe thyroid eye disease
Ia期:评估SCTT11在健康受试者中单次给药的安全性和耐受性,确定MTD
Ib期:评估SCTT11多次给药治疗中重度活动性TED患者的安全性和耐受性,确定MTD;确定SCTT11在中重度活动性TED患者中的Ⅱ期推荐剂量(RP2D)
[Translation] Phase Ia: Evaluate the safety and tolerability of a single dose of SCTT11 in healthy subjects and determine the MTD
Phase Ib: Evaluate the safety and tolerability of multiple doses of SCTT11 in patients with moderate to severe active TED and determine the MTD; determine the Phase II recommended dose (RP2D) of SCTT11 in patients with moderate to severe active TED