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

NCT05584306 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-10-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qinghong Zhou, MD · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

  • Xin Zhou, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  • Min Zhang, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584306 on ClinicalTrials.gov