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Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

Primary Purpose

Systemic Juvenile Idiopathic Arthritis, Periodic Fever Syndrome

Status
Unknown status
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 Systemic Juvenile Idiopathic Arthritis

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
  • Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3 months after finished the study
  • 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
  • Participants could communicate well with the researchers and compliance with the trial

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 3-6 months before screening, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
  • Clinical laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.), auxiliary examinations (chest X-ray, abdominal ultrasound) 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
  • Those who smoked more than 5 cigarettes per day during the 3 months before screening, or have a positive urine nicotine screening test (screening period or baseline period)
  • 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 (morphine, Ketamine, tetrahydrocannabinol acid, methamphetamine , dimethyldioxyamphetamine, cocaine)
  • Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 14 days before administration
  • Has received any monoclonal antibody drugs within 3 months before administration
  • Has a history of vaccination within 3 months before dosing, or intend to receive vaccines during the study
  • Was previously enrolled in other clinical trials within 3 months before dosing
  • Blood donors or subjects who lost a lot of blood (> 400 mL, except for women's physiological period) or those who received blood transfusion or used blood products within 3 months
  • Can't tolerate venipuncture or has a history of halo needles and halo blood
  • Has known or suspected pregnancy or lactation
  • Abnormal vital signs (SBP <90 mmHg or ≥140 mmHg, DBP <55 mmHg or ≥90 mmHg; heart rate <50 bpm or> 100 bpm; body temperature <35.4℃ or > 37.3℃) or abnormal ECG (QTcF ≥450 ms) or physical examination are clinically significant (according to the judgment of clinical research doctors)
  • Those who are infected and need to be treated for acute or chronic infections, as follows:

    • Suffering from herpes zoster within 12 months before screening;
    • Currently in any inhibitory treatment for chronic infections (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster virus, and atypical mycobacteria);
    • A history of tuberculosis or contact with patients with open tuberculosis in the past 6 months,or a T-spoT-positive results;
    • Infected with parasites within 3 months before administration;
    • Hospitalized for infectious diseases within 30 days before administration;
    • Received anti-infective drugs (including antibacterial, antiviral, antifungal, or antiparasitic drugs) by parenteral administration (iv or im) 30 days before administration
  • Subjects who are unsuited to the study for any reason, judged by the investigators

Sites / Locations

  • Shanghai Xuhui District Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SSGJ-613

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Cmax
Tmax
AUC0-t
t1/2
CL/F
Vd/F
Ke
AUC0-∞
AE
SAE

Secondary Outcome Measures

total IL-1β
free IL-1β
ADA
Bridging method will be used to detect the incidence and titer for ADA through one three-step detection strategy, that is preliminary screening, confirmation and titer

Full Information

First Posted
August 17, 2021
Last Updated
August 27, 2021
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05027373
Brief Title
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
Official Title
A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (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
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.
Detailed Description
This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody by single subcutaneous injection with five different doses in healthy subjects. There are 5 groups as follows: 0.03mg/kg (S1), 1.0mg/kg (S2), 3.0mg/kg (S3), 6.0mg/kg (S4) and 10.0mg/kg (S5); and 2 subjects were included in the S1 group (both received study drugs); 8 subjects were included in each of the S2 ~ S5 groups (of which 6 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Juvenile Idiopathic Arthritis, Periodic Fever Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSGJ-613
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SSGJ-613
Intervention Description
SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.
Primary Outcome Measure Information:
Title
Cmax
Time Frame
up to 112 days
Title
Tmax
Time Frame
up to 112 days
Title
AUC0-t
Time Frame
up to 112 days
Title
t1/2
Time Frame
up to 112 days
Title
CL/F
Time Frame
up to 112 days
Title
Vd/F
Time Frame
up to 112 days
Title
Ke
Time Frame
up to 112 days
Title
AUC0-∞
Time Frame
up to 112 days
Title
AE
Time Frame
up to 112 days
Title
SAE
Time Frame
up to 112 days
Secondary Outcome Measure Information:
Title
total IL-1β
Time Frame
up to 112 days
Title
free IL-1β
Time Frame
up to 112 days
Title
ADA
Description
Bridging method will be used to detect the incidence and titer for ADA through one three-step detection strategy, that is preliminary screening, confirmation and titer
Time Frame
up to 112 days

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 Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3 months after finished the study 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 Participants could communicate well with the researchers and compliance with the trial 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 3-6 months before screening, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results Clinical laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.), auxiliary examinations (chest X-ray, abdominal ultrasound) 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 Those who smoked more than 5 cigarettes per day during the 3 months before screening, or have a positive urine nicotine screening test (screening period or baseline period) 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 (morphine, Ketamine, tetrahydrocannabinol acid, methamphetamine , dimethyldioxyamphetamine, cocaine) Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 14 days before administration Has received any monoclonal antibody drugs within 3 months before administration Has a history of vaccination within 3 months before dosing, or intend to receive vaccines during the study Was previously enrolled in other clinical trials within 3 months before dosing Blood donors or subjects who lost a lot of blood (> 400 mL, except for women's physiological period) or those who received blood transfusion or used blood products within 3 months Can't tolerate venipuncture or has a history of halo needles and halo blood Has known or suspected pregnancy or lactation Abnormal vital signs (SBP <90 mmHg or ≥140 mmHg, DBP <55 mmHg or ≥90 mmHg; heart rate <50 bpm or> 100 bpm; body temperature <35.4℃ or > 37.3℃) or abnormal ECG (QTcF ≥450 ms) or physical examination are clinically significant (according to the judgment of clinical research doctors) Those who are infected and need to be treated for acute or chronic infections, as follows: Suffering from herpes zoster within 12 months before screening; Currently in any inhibitory treatment for chronic infections (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster virus, and atypical mycobacteria); A history of tuberculosis or contact with patients with open tuberculosis in the past 6 months,or a T-spoT-positive results; Infected with parasites within 3 months before administration; Hospitalized for infectious diseases within 30 days before administration; Received anti-infective drugs (including antibacterial, antiviral, antifungal, or antiparasitic drugs) by parenteral administration (iv or im) 30 days before administration 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
Qian Chen, PhD
Phone
02154030254
Email
qchen@shxh-centerlab.com
Facility Information:
Facility Name
Shanghai Xuhui District Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan Lu

12. IPD Sharing Statement

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Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

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