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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05966701
Other study ID # SSGJ-613-HH-I-02
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 10, 2023
Est. completion date March 10, 2024

Study information

Verified date July 2023
Source Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Contact Qinghong Zhou, BS
Phone +86 18911301578
Email zhouqinghong@3sbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date March 10, 2024
Est. primary completion date March 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SSGJ-613
SSGJ-613 subcutaneous injection.
Placebo
Placebo subcutaneous injection.

Locations

Country Name City State
China Shanghai Xuhui District Central Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit. 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.. Up to Day 174
Secondary SSGJ-613 Concentration in Serum The concentration of SSGJ-613 in Serum. Up to Day 174
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