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The MAD Study of SSGJ-613 in Healthy Subjects

Primary Purpose

Arthritis, Gouty

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SSGJ-613
Placebo
Sponsored by
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Gouty

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Shanghai Xuhui District Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SSGJ-613

Placebo

Arm Description

SSGJ-613,SC

Placebo, SC

Outcomes

Primary Outcome Measures

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..

Secondary Outcome Measures

SSGJ-613 Concentration in Serum
The concentration of SSGJ-613 in Serum.

Full Information

First Posted
July 20, 2023
Last Updated
July 20, 2023
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05966701
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
March 10, 2024 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Gouty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSGJ-613
Arm Type
Experimental
Arm Description
SSGJ-613,SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, SC
Intervention Type
Drug
Intervention Name(s)
SSGJ-613
Intervention Description
SSGJ-613 subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection.
Primary Outcome Measure Information:
Title
Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit.
Description
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..
Time Frame
Up to Day 174
Secondary Outcome Measure Information:
Title
SSGJ-613 Concentration in Serum
Description
The concentration of SSGJ-613 in Serum.
Time Frame
Up to Day 174

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghong Zhou, BS
Phone
+86 18911301578
Email
zhouqinghong@3sbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghong Zhou, BS
Organizational Affiliation
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qian Chen, PhD
Organizational Affiliation
Shanghai Xuhui District Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xuhui District Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Chen, PhD
Phone
021-54030254
Email
qchen@shxh-centerlab.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The MAD Study of SSGJ-613 in Healthy Subjects

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