drugset
drugset / Trial / NCT04445038

Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection

NCT04445038 ↗

Phase 1 Unknown 52 enrolled Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 \~ S6 groups (of which 8 received study drugs and 2 received placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.

Timeline

Start
2020-06-12
Primary completion
2021-03-01
Completion
2021-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 610 Monoclonal antibody 0.03 mg/kg Subcutaneous
Subject 610 Monoclonal antibody 0.2 mg/kg Subcutaneous
Subject 610 Monoclonal antibody 1 mg/kg Subcutaneous
Subject 610 Monoclonal antibody 3 mg/kg Subcutaneous
Subject 610 Monoclonal antibody 5 mg/kg Subcutaneous
Subject 610 Monoclonal antibody 7.5 mg/kg Subcutaneous

Indications

No indication recorded.