Systemic Juvenile Idiopathic ArthritisPhase 1NCT05027373
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
A Phase 1 study testing SSGJ-613 in people with Systemic Juvenile Idiopathic Arthritis and Periodic Fever Syndrome, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Juvenile Idiopathic Arthritis, Periodic Fever Syndrome
- What is being tested?
- SSGJ-613
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2021to 30 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 201203
Chuan Lu
About this study
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
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.
Read the 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.
- Being tested
- SSGJ-613, Placebo
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-613Drug
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.
PlaceboDrug
Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-613 | Experimental | Not described Receives: Drug: SSGJ-613 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: up to 112 days
Tmax
Measured: up to 112 days
AUC0-t
Measured: up to 112 days
t1/2
Measured: up to 112 days
CL/F
Measured: up to 112 days
Vd/F
Measured: up to 112 days
Ke
Measured: up to 112 days
AUC0-∞
Measured: up to 112 days
AE
Measured: up to 112 days
SAE
Measured: up to 112 days
Secondary outcomes (3)
total IL-1β
Measured: up to 112 days
free IL-1β
Measured: up to 112 days
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
Measured: up to 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Aug 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027373
- Sponsor's protocol ID
- SSGJ-613-HH-I-01
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05027373
- Acronym / sponsor ID
- SSGJ-613-HH-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSGJ-613 | Experimental | Drug: SSGJ-613 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSGJ-613SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint. | Drug | SSGJ-613 |
| PlaceboPlacebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless. | Drug | Placebo |
Primary outcome
Cmax
Time frame: up to 112 days
Tmax
Time frame: up to 112 days
AUC0-t
Time frame: up to 112 days
t1/2
Time frame: up to 112 days
CL/F
Time frame: up to 112 days
Vd/F
Time frame: up to 112 days
Ke
Time frame: up to 112 days
AUC0-∞
Time frame: up to 112 days
AE
Time frame: up to 112 days
SAE
Time frame: up to 112 days
3 secondary outcomes
total IL-1β
Time frame: up to 112 days
free IL-1β
Time frame: up to 112 days
ADA
Time frame: up to 112 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSGJ-613 in people with Systemic Juvenile Idiopathic Arthritis and Periodic Fever Syndrome, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Chen, PhD (02154030254, qchen@shxh-centerlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 112 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.