The MAD Study of SSGJ-613 in Healthy Subjects

Sunshine Guojian Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Arthritis, Gouty

Treatments: Drug: SSGJ-613; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05966701

SSGJ-613-HH-I-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

SSGJ-613

Experimental group

Description:

SSGJ-613，SC

Treatment:

Drug: SSGJ-613

Placebo

Placebo Comparator group

Description:

Placebo, SC

Treatment:

Drug: Placebo