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Efficacy and Safety Study of 610 in Patients With Severe Asthma

RECRUITINGPhase 3Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Actively Recruiting
PhasePhase 3
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Started2024-06-24
Est. completion2027-02
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Exclusion Criteria:

1. Presence of a known pre-existing, clinically important lung condition other than asthma.
2. Severe asthma exacerbation within 4 weeks prior to randomization.
3. Subjects with any eosinophilic diseases other than asthma.
4. Known, pre-existing severe or clinically significant cardiovascular disease.
5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
7. Subjects with allergy/intolerance to a monoclonal antibody.

Conditions1

Asthma

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