SG301-SC Injection Safety Study in Subjects With Primary ITP Patients
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Safety and Efficacy of SG301 SC Injection in Patients With Primary Immune Thrombocytopenia
Hangzhou Sumgen Biotech Co., Ltd.
60 participants
Jun 11, 2026
INTERVENTIONAL
Conditions
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective is to evaluate the safety and efficacy of SG301 SC Injection in participants with ITP, while the secondary objectives are to assess the pharmacokinetic, pharmacodynamic and immunogenicity profiles of SG301 SC Injection in ITP participants. A total of 60 ITP participants are planned to be enrolled in this study and randomly assigned at a 1:1:1 ratio to the low dose group, high dose group and placebo group, with approximately 20 participants per group. All participants enrolled in this study may receive concomitant background therapies at stable doses for at least 4 weeks prior to the first study drug administration, and is expected to be maintained throughout the study period.
Eligibility
Plain Language Summary
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Interventions
SG301 SC weekly for a total of 8 doses, subcutaneous injection
SG301 SC weekly for a total of 8 doses , subcutaneous injection
SG301 SC Placebo weekly for a total of 8 doses, subcutaneous injection
Locations(22)
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NCT07710248