The MAD Study of SSGJ-613 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalation Phase I Clinical Study of Humanized Monoclonal Antibody Injection (SSGJ-613) in Healthy Adult Chinese Subjects

NCT05966701•Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

ALL

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

Locations (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 10, 2023

Primary Completion Date

March 10, 2024

Completion Date

March 10, 2024

Last Updated

August 1, 2023

Enrollment

ESTIMATED participants

Conditions

Arthritis, Gouty

Interventions

SSGJ-613

DRUG

Placebo

DRUG

Contacts

Qinghong Zhou, BS

CONTACT

+86 18911301578 zhouqinghong@3sbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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