Arthritis, Gouty
Conditions
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.
Interventions
DRUGSSGJ-613
SSGJ-613 subcutaneous injection.
DRUGPlacebo
Placebo subcutaneous injection.
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese healthy participants, male or female, aged 18 to 45 (including both ends) 2. 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 3. 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 criteria
1. Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies 2. Subjects who have or are currently suffering from any serious clinical diseases before screening, 3. Abnormal vital signs or abnormal ECGor physical examination are clinically significant 4. Clinical laboratory examinations found to be abnormal and have clinical significance 5. Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV) 6. 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 7. 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 8. Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration 9. Has known or suspected pregnancy or lactation 10. Subjects who are unsuited to the study for any reason, judged by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. | Up to Day 174 | The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSGJ-613 Concentration in Serum | Up to Day 174 | The concentration of SSGJ-613 in Serum. |
Countries
China
Contacts
Primary ContactQinghong Zhou, BS
Outcome results
None listed