- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05027373
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
August 27, 2021 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qian Chen, PhD
- Phone Number: 02154030254
- Email: qchen@shxh-centerlab.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201203
- Recruiting
- Shanghai Xuhui District Central Hospital
-
Contact:
- Chuan Lu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.
|
Experimental: SSGJ-613
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax
Time Frame: up to 112 days
|
up to 112 days
|
Tmax
Time Frame: up to 112 days
|
up to 112 days
|
AUC0-t
Time Frame: up to 112 days
|
up to 112 days
|
t1/2
Time Frame: up to 112 days
|
up to 112 days
|
CL/F
Time Frame: up to 112 days
|
up to 112 days
|
Vd/F
Time Frame: up to 112 days
|
up to 112 days
|
Ke
Time Frame: up to 112 days
|
up to 112 days
|
AUC0-∞
Time Frame: up to 112 days
|
up to 112 days
|
AE
Time Frame: up to 112 days
|
up to 112 days
|
SAE
Time Frame: up to 112 days
|
up to 112 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total IL-1β
Time Frame: up to 112 days
|
up to 112 days
|
|
free IL-1β
Time Frame: up to 112 days
|
up to 112 days
|
|
ADA
Time Frame: up to 112 days
|
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
|
up to 112 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2021
Primary Completion (Anticipated)
April 30, 2022
Study Completion (Anticipated)
September 30, 2022
Study Registration Dates
First Submitted
August 17, 2021
First Submitted That Met QC Criteria
August 27, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 27, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSGJ-613-HH-I-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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