The MAD Study of SSGJ-613 in Healthy Subjects

Arthritis, Gouty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05966701
• Other study ID #: SSGJ-613-HH-I-02
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Arthritis, Gouty

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