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drugset / Trial / NCT04178070

Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects

NCT04178070 ↗

Phase 1 Unknown 58 enrolled Genor Biopharma Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects.

Timeline

Start
2017-11-06
Primary completion
2020-12
Completion
2021-04

Drugs

EvaluationDrugModalityDoseRoute
Subject GB224 Unknown 2 mg Subcutaneous
Subject GB224 Unknown 5 mg Subcutaneous
Subject GB224 Unknown 10 mg Subcutaneous
Subject GB224 Unknown 15 mg Subcutaneous
Subject GB224 Unknown 20 mg Subcutaneous
Subject GB224 Unknown 30 mg Subcutaneous

Indications

rheumatoid arthritis