A Study of STSA-1002 in Healthy Subjects

Phase 1 Completed 26 enrolled Staidson (Beijing) Biopharmaceuticals Co., Ltd

RandomizedSequentialQuadruple-blindTreatment

Summary

This study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002 injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage groups.

Timeline

Start: 2022-10-14
Primary completion: 2023-04-06
Completion: 2023-04-06

Publications

Fang Y, Wang X, Qi L, Tong Y, Wei Y, Li Z, Liu C, Liu J, Cheng X, Liu X, Liu F, Li Y, Li Y, Liu L, Sun M, Wang Y, Wang X. Safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of STSA-1002, recombinant anti-human C5a fully human monoclonal antibody, in a randomized, first-in-human phase I study in healthy adults. Front Pharmacol. 2026 Jun 18;17:1838620. doi: 10.3389/fphar.2026.1838620. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GREZIPRUBART	Monoclonal antibody	5 mg/kg	Intravenous
Subject	GREZIPRUBART	Monoclonal antibody	10 mg/kg	Intravenous
Subject	GREZIPRUBART	Monoclonal antibody	20 mg/kg	Intravenous

Indications

No indication recorded.