Status:
UNKNOWN
The MAD Study of SSGJ-613 in Healthy Subjects
Lead Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions:
Arthritis, Gouty
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
Detailed Description
The purposes of this study are to evaluate the safety and tolerability, PK characteristics and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
Eligibility Criteria
Inclusion
- Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
- The body mass index (BMI) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
Exclusion
- Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
- Subjects who have or are currently suffering from any serious clinical diseases before screening,
- Abnormal vital signs or abnormal ECGor physical examination are clinically significant
- Clinical laboratory examinations found to be abnormal and have clinical significance
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
- Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
- Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening
- Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration
- Has known or suspected pregnancy or lactation
- Subjects who are unsuited to the study for any reason, judged by the investigators
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05966701
Start Date
August 10 2023
End Date
March 10 2024
Last Update
August 1 2023
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China, 200031