Clinical trial NCT05966701: The MAD Study of SSGJ-613 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Arthritis, Gouty
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
timeFrame: Up to Day 174
Secondary outcomes:
measure: SSGJ-613 Concentration in Serum
timeFrame: Up to Day 174
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui District Central Hospital
state: Shanghai
Study officials:
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, BS
role: STUDY_DIRECTOR
affiliation: Shanghai Xuhui District Central Hospital
name: Qian Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: