The MAD Study of SSGJ-613 in Healthy Subjects

NCT ID: NCT05966701

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2024-03-10

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.

Conditions

Arthritis, Gouty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SSGJ-613

SSGJ-613，SC

Group Type: EXPERIMENTAL

SSGJ-613

Intervention Type: DRUG

SSGJ-613 subcutaneous injection.

Placebo

Placebo, SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo subcutaneous injection.

Interventions

SSGJ-613

SSGJ-613 subcutaneous injection.

Intervention Type: DRUG

Placebo

Placebo subcutaneous injection.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qinghong Zhou, BS

Role: STUDY_DIRECTOR

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Qian Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Xuhui District Central Hospital

Locations

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Qinghong Zhou, BS

Role: CONTACT

zhouqinghong@3sbio.com

+86 18911301578

Facility Contacts

Qian Chen, PhD

Role: primary

qchen@shxh-centerlab.com

021-54030254

Other Identifiers

SSGJ-613-HH-I-02

Identifier Type: -

Identifier Source: org_study_id