The MAD Study of SSGJ-613 in Healthy Subjects

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Arthritis, Gouty

See also
Status	Clinical Trial	Phase
Completed	`NCT05119686` - Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients	Phase 2
Completed	`NCT00549549` - Celebrex In Acute Gouty Arthritis Study	Phase 3
Active, not recruiting	`NCT05253833` - Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout	Phase 2
Completed	`NCT00663169` - Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT05119686 - Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

Phase 2

Completed

NCT00549549 - Celebrex In Acute Gouty Arthritis Study

Phase 3

Active, not recruiting

NCT05253833 - Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

Phase 2

Completed

NCT00663169 - Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05966701
Study type	Interventional
Source	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Contact	Qinghong Zhou, BS
Phone	+86 18911301578
Email	zhouqinghong@3sbio.com
Status	Not yet recruiting
Phase	Phase 1
Start date	August 10, 2023
Completion date	March 10, 2024

The MAD Study of SSGJ-613 in Healthy Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms