NCT05584306

A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	610 30mg group	610 30mg subcutaneous (SC) Q4W，8 times
DRUG	610 100mg group	610 100mg subcutaneous (SC) Q4W，8 times
DRUG	610 300mg group	610 300mg subcutaneous (SC) Q4W，8 times
OTHER	Placebo 30mg group	placebo subcutaneous (SC) Q4W，8 times
OTHER	Placebo 100mg group	placebo subcutaneous (SC) Q4W，8 times
OTHER	Placebo 300mg group	placebo subcutaneous (SC) Q4W，8 times

Timeline

• Start date: 2021-12-06
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-10-18
• Last updated: 2022-10-18

Locations

1 site across 1 country: China