The MAD Study of SSGJ-613 in Healthy Subjects

NCT05966701 | Unknown Phase 1

• 1 other identifier: SSGJ-613-HH-I-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthritis, Gouty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SSGJ-613 Concentration in Serum

  Up to Day 174

Study Arms (2)

SSGJ-613

EXPERIMENTAL

SSGJ-613，SC

Drug: SSGJ-613

Placebo

PLACEBO COMPARATOR

Placebo, SC

Drug: Placebo

Interventions

SSGJ-613 DRUG

SSGJ-613 subcutaneous injection.

SSGJ-613

Placebo DRUG

Placebo subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
• 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
• 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

You may not qualify if:

• Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
• Subjects who have or are currently suffering from any serious clinical diseases before screening,
• Abnormal vital signs or abnormal ECGor physical examination are clinically significant
• Clinical laboratory examinations found to be abnormal and have clinical significance
• Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
• 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
• 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
• Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration
• Has known or suspected pregnancy or lactation
• Subjects who are unsuited to the study for any reason, judged by the investigators

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Arthritis, Gouty

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Qinghong Zhou, BS

  Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

  STUDY DIRECTOR

• Qian Chen, PhD

  Shanghai Xuhui District Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Zhou, BS

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: August 10, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)