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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis, Gouty
• Intervention / Treatment: Drug: Placebo; Drug: SSGJ-613

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qinghong Zhou, BS; Phone Number: +86 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui District Central Hospital
      • Contact: Qian Chen, PhD; Phone Number: 021-54030254; Email: qchen@shxh-centerlab.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSGJ-613; SSGJ-613，SC	Drug: SSGJ-613; SSGJ-613 subcutaneous injection.
Placebo Comparator: Placebo; Placebo, SC	Drug: Placebo; Placebo subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSGJ-613 Concentration in Serum	The concentration of SSGJ-613 in Serum.	Up to Day 174

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Investigators: Study Director: Qinghong Zhou, BS, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.; Principal Investigator: Qian Chen, PhD, Shanghai Xuhui District Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2023
• Primary Completion (Estimated): March 10, 2024
• Study Completion (Estimated): March 10, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis, Gouty
• Other Study ID Numbers: SSGJ-613-HH-I-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No