Rheumatoid ArthritisPhase 1NCT04178070
Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects
A Phase 1 study testing GB224 2mg, GB224 5mg and GB224 10mg in people with Rheumatoid Arthritis, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GB224 2mg, GB224 5mg and GB224 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2017to Apr 2021
- 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
- Understand the study procedures and contents, and voluntarily sign the informed consent form;
- Chinese healthy adult volunteers aged 18 to 45 years, males and females;
- The subjects have qualified physical examination within 30 days before the study, the body mass index (BMI) is within the range of 19~24 and the body weight is within the range of 45~75kg;
- Males or females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study.
- The investigator considers that the patients have good health condition according to the physical examination, medical history, vital signs and ECG etc.
- Patients have good compliance, can receive follow-up visits as scheduled, are able to well communicate with the investigators and complete the study as required by the study.
Who cannot join
- Any of the following is met: allergic constitution; known allergic to the components of the investigational product or allergy history to any drug or food or pollen; subjects who have medical history of skin allergy such as physical urticaria; subjects who have abnormal serum immunoglobulin E (IgE) test;
- Any of the current symptoms, signs or laboratory test abnormalities indicating the possible presence of acute or subacute infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.)
- Patients with active pulmonary tuberculosis; patients who previously had medical history of active pulmonary tuberculosis;
- Subjects who have medical history of drug addiction or drug abuse;
- Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; subjects with medical history of hypertension or screening systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, which are clinically significant at the discretion of the investigators; subjects who have medical history of orthostatic hypotension;
- Subjects who have medical history of malignant tumors;
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- Subjects who participated in other clinical studies within 3 months before enrollment, or subjects who received drugs which are known to injure the major organs within 3 months before enrollment;
- Subjects who used prescription drugs or non-prescription drugs within 14 days before enrollment;
- Subjects who have blood donation history within 3 months before enrollment;
- Subjects who meet any of the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN), serum creatinine (Cr) > the upper limit of normal (ULN);
- Abnormal routine blood tests: any of the following is met: white blood cells (WBC)<3.0×109/L or >9.5×109/L, neutrophil count (ANC)<1.5×109/L, platelet count (PLT)<100×109/L, hemoglobin (HGB)<104g/L;
- Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);
- Subjects who have positive tuberculosis skin test (5 units of dosage, induration of not less than 5 millimeters (mm) within 48 ~ 72 hours);
- Subjects with positive anti-nuclear antibody (ANA), anti-double stranded DNA antibody (ds-DNA) and anti-extractable nuclear antigens (ENA);
- Subjects with positive anti-drug antibody (ADA);
- Subjects with positive tumor markers (CEA, AFP, PSA and CA-125);
- Subjects with abnormal coagulation function, which is clinically significant at the discretion of the investigators;
- Subjects with medical history of psychiatric disorders;
- Smoking more than 5 cigarettes/day or equivalent tobacco;
- Weekly alcohol consumption more than 28 units (1 unit = 285 mL of beer or 25 mL of spirits or a glass of wine); or subjects who have positive breath alcohol test within 24 hours before the use of investigational drug;
- Subjects who have clinically significant abnormal laboratory test values at screening;
- Female subjects who have positive serum/urine pregnancy tests at screening or lactating women;
- Patients who have insufficient communication, understanding and cooperation; or patients who have poor compliance and cannot guarantee to strictly follow the study protocol;
- Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100191
Yi Fang, Ph.D, 010-66583834
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase Ⅰ Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GB224 2mg, GB224 5mg, GB224 10mg, GB224 15mg, GB224 20mg
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB224 2mgBiological
Also called Gerilimzumab injection
2mg (100μL), single dose, abdominal subcutaneous injection
GB224 5mgBiological
Also called Gerilimzumab injection
5mg (250μL), single dose, abdominal subcutaneous injection
GB224 10mgBiological
Also called Gerilimzumab injection
10mg (500μL), single dose, abdominal subcutaneous injection
GB224 15mgBiological
Also called Gerilimzumab injection
15mg (750μL), single dose, abdominal subcutaneous injection
GB224 20mgBiological
Also called Gerilimzumab injection
20mg (1mL), single dose, abdominal subcutaneous injection
GB224 30mgBiological
Also called Gerilimzumab injection
30mg (1.5mL), single dose, abdominal subcutaneous injection
Placebo, 2mgOther
2mg (100μL), single dose, abdominal subcutaneous injection
Placebo, 5mgOther
5mg (250μL), single dose, abdominal subcutaneous injection
Placebo, 10mgOther
10mg (500μL), single dose, abdominal subcutaneous injection
Placebo, 15mgOther
15mg (750μL), single dose, abdominal subcutaneous injection
Placebo, 20mgOther
20mg (1mL), single dose, abdominal subcutaneous injection
Placebo, 30mgOther
30mg (1.5mL), single dose, abdominal subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| GB224 2mg | Experimental | single dose Receives: Biological: GB224 2mg |
| GB224 5mg | Experimental | single dose Receives: Biological: GB224 5mg |
| GB224 10mg | Experimental | single dose Receives: Biological: GB224 10mg |
| GB224 15mg | Experimental | single dose Receives: Biological: GB224 15mg |
| GB224 20mg | Experimental | single dose Receives: Biological: GB224 20mg |
| GB224 30mg | Experimental | single dose Receives: Biological: GB224 30mg; Other: Placebo, 30mg |
| Placebo 2mg | Placebo comparator | single dose Receives: Other: Placebo, 2mg |
| Placebo 5mg | Placebo comparator | single dose Receives: Other: Placebo, 5mg |
| Placebo 10mg | Placebo comparator | single dose Receives: Other: Placebo, 10mg |
| Placebo 15mg | Placebo comparator | single dose Receives: Other: Placebo, 15mg |
| Placebo 20mg | Placebo comparator | single dose Receives: Other: Placebo, 20mg |
| Placebo 30mg | Placebo comparator | single dose Receives: Other: Placebo, 30mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adeverse Effect, AE
Adeverse Effect, AE
Measured: Up to 112 days.
Serious Adeverse Effect, AE
Serious Adeverse Effect, AE
Measured: Up to 112 days.
Maximum Tolerated Dose, MTD
Maximum Tolerated Dose, MTD
Measured: Up to 112 days.
Dose Limited Toxicity, DLT
Dose Limited Toxicity, DLT
Measured: Up to 112 days.
Secondary outcomes (9)
AUC0-t
AUC0-t
Measured: Up to 112 days.
Cmax
Cmax
Measured: Up to 112 days.
AUC0-∞
AUC0-∞
Measured: Up to 112 days.
Tmax
Tmax
Measured: Up to 112 days.
Vd
Vd
Measured: Up to 112 days.
Ke
Ke
Measured: Up to 112 days.
Mean Retention Time, MRT
Mean Retention Time, MRT
Measured: Up to 112 days.
t1/2
t1/2
Measured: Up to 112 days.
CL
CL
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 posted26 Nov 2019
- Study start6 Nov 2017
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Fang, Ph.D, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178070
- Sponsor's protocol ID
- GENOR GB224-001; V1.4
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 27 Nov 2019
- 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 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase Ⅰ Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT04178070
- Acronym / sponsor ID
- GENOR GB224-001; V1.4
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 26 Nov 2019 (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.
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| GB224 2mg | Experimental | Biological: GB224 2mgsingle dose |
| GB224 5mg | Experimental | Biological: GB224 5mgsingle dose |
| GB224 10mg | Experimental | Biological: GB224 10mgsingle dose |
| GB224 15mg | Experimental | Biological: GB224 15mgsingle dose |
| GB224 20mg | Experimental | Biological: GB224 20mgsingle dose |
| GB224 30mg | Experimental | Biological: GB224 30mg, Other: Placebo, 30mgsingle dose |
| Placebo 2mg | Placebo comparator | Other: Placebo, 2mgsingle dose |
| Placebo 5mg | Placebo comparator | Other: Placebo, 5mgsingle dose |
| Placebo 10mg | Placebo comparator | Other: Placebo, 10mgsingle dose |
| Placebo 15mg | Placebo comparator | Other: Placebo, 15mgsingle dose |
| Placebo 20mg | Placebo comparator | Other: Placebo, 20mgsingle dose |
| Placebo 30mg | Placebo comparator | Other: Placebo, 30mgsingle dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understand the study procedures and contents, and voluntarily sign the informed consent form;
- Chinese healthy adult volunteers aged 18 to 45 years, males and females;
- The subjects have qualified physical examination within 30 days before the study, the body mass index (BMI) is within the range of 19~24 and the body weight is within the range of 45~75kg;
- Males or females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study.
- The investigator considers that the patients have good health condition according to the physical examination, medical history, vital signs and ECG etc.
Key exclusion criteria (24 listed)
- Any of the following is met: allergic constitution; known allergic to the components of the investigational product or allergy history to any drug or food or pollen; subjects who have medical history of skin allergy such as physical urticaria; subjects who have abnormal serum immunoglobulin E (IgE) test;
- Any of the current symptoms, signs or laboratory test abnormalities indicating the possible presence of acute or subacute infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.)
- Patients with active pulmonary tuberculosis; patients who previously had medical history of active pulmonary tuberculosis;
- Subjects who have medical history of drug addiction or drug abuse;
- Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; subjects with medical history of hypertension or screening systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, which are clinically significant at the discretion of the investigators; subjects who have medical history of orthostatic hypotension;
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 |
|---|---|---|
| GB224 2mgAlso: Gerilimzumab injection2mg (100μL), single dose, abdominal subcutaneous injection | Biological | GB224 2mg |
| GB224 5mgAlso: Gerilimzumab injection5mg (250μL), single dose, abdominal subcutaneous injection | Biological | GB224 5mg |
| GB224 10mgAlso: Gerilimzumab injection10mg (500μL), single dose, abdominal subcutaneous injection | Biological | GB224 10mg |
| GB224 15mgAlso: Gerilimzumab injection15mg (750μL), single dose, abdominal subcutaneous injection | Biological | GB224 15mg |
| GB224 20mgAlso: Gerilimzumab injection20mg (1mL), single dose, abdominal subcutaneous injection | Biological | GB224 20mg |
| GB224 30mgAlso: Gerilimzumab injection30mg (1.5mL), single dose, abdominal subcutaneous injection | Biological | GB224 30mg |
| Placebo, 2mg2mg (100μL), single dose, abdominal subcutaneous injection | Other | Placebo 2mg |
| Placebo, 5mg5mg (250μL), single dose, abdominal subcutaneous injection | Other | Placebo 5mg |
| Placebo, 10mg10mg (500μL), single dose, abdominal subcutaneous injection | Other | Placebo 10mg |
| Placebo, 15mg15mg (750μL), single dose, abdominal subcutaneous injection | Other | Placebo 15mg |
| Placebo, 20mg20mg (1mL), single dose, abdominal subcutaneous injection | Other | Placebo 20mg |
| Placebo, 30mg30mg (1.5mL), single dose, abdominal subcutaneous injection | Other | GB224 30mg, Placebo 30mg |
Primary outcome
Adeverse Effect, AE
Time frame: Up to 112 days.
Adeverse Effect, AE
Serious Adeverse Effect, AE
Time frame: Up to 112 days.
Serious Adeverse Effect, AE
Maximum Tolerated Dose, MTD
Time frame: Up to 112 days.
Maximum Tolerated Dose, MTD
Dose Limited Toxicity, DLT
Time frame: Up to 112 days.
Dose Limited Toxicity, DLT
9 secondary outcomes
AUC0-t
Time frame: Up to 112 days.
Cmax
Time frame: Up to 112 days.
AUC0-∞
Time frame: Up to 112 days.
Tmax
Time frame: Up to 112 days.
Vd
Time frame: Up to 112 days.
Ke
Time frame: Up to 112 days.
Mean Retention Time, MRT
Time frame: Up to 112 days.
t1/2
Time frame: Up to 112 days.
CL
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 27 Nov 2019.
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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.
Yi Fang, Ph.D principal investigator
Peking University People's Hospital
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 GB224 2mg, GB224 5mg and GB224 10mg in people with Rheumatoid Arthritis, run by Genor Biopharma 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 6 inclusion and 24 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 27 Nov 2019. 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 Shawn Yu, Master (010-65260820, Shawn.Yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adeverse Effect, AE (time frame: Up to 112 days.). The study lists 4 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 27 Nov 2019.