Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects and Psoriasis Subjects
This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.
• Adults aged between 18 and 75 years (inclusive)，both male and female；
• A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017；
• Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
• Body mass index (BMI) within 18\
⁃ 36 kg/m2；
• Major organ function is good;
• Patients must be able to understand and sign a written informed consent document;
• Patients must be able to complete study-related procedures and questionnaires;
• Female and male subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Female subjects need to serum pregnancy pregnancy test within 7 days before study enrollment.