NCT04445038

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

A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by single subcutaneous injection with six different doses 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). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.

Conditions

• add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma

Interventions

Type	Name	Description
DRUG	610	Recombinant anti-IL-5 Humanized Monoclonal Antibody
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-06-12
• Primary completion: 2021-03-01
• Completion: 2021-06-01
• First posted: 2020-06-24
• Last updated: 2021-01-28

Locations

1 site across 1 country: China