- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178070
Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects
November 25, 2019 updated by: Genor Biopharma Co., Ltd.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
58
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 Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Peking University People's Hospital
-
Contact:
- Yi Fang, Ph.D
- Phone Number: 010-66583834
-
-
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:
- 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.
Exclusion Criteria:
- 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;
- 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.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GB224 2mg
single dose
|
2mg (100μL), single dose, abdominal subcutaneous injection
Other Names:
|
Experimental: GB224 5mg
single dose
|
5mg (250μL), single dose, abdominal subcutaneous injection
Other Names:
|
Experimental: GB224 10mg
single dose
|
10mg (500μL), single dose, abdominal subcutaneous injection
Other Names:
|
Experimental: GB224 15mg
single dose
|
15mg (750μL), single dose, abdominal subcutaneous injection
Other Names:
|
Experimental: GB224 20mg
single dose
|
20mg (1mL), single dose, abdominal subcutaneous injection
Other Names:
|
Experimental: GB224 30mg
single dose
|
30mg (1.5mL), single dose, abdominal subcutaneous injection
Other Names:
30mg (1.5mL), single dose, abdominal subcutaneous injection
|
Placebo Comparator: Placebo 2mg
single dose
|
2mg (100μL), single dose, abdominal subcutaneous injection
|
Placebo Comparator: Placebo 5mg
single dose
|
5mg (250μL), single dose, abdominal subcutaneous injection
|
Placebo Comparator: Placebo 10mg
single dose
|
10mg (500μL), single dose, abdominal subcutaneous injection
|
Placebo Comparator: Placebo 15mg
single dose
|
15mg (750μL), single dose, abdominal subcutaneous injection
|
Placebo Comparator: Placebo 20mg
single dose
|
20mg (1mL), single dose, abdominal subcutaneous injection
|
Placebo Comparator: Placebo 30mg
single dose
|
30mg (1.5mL), single dose, abdominal subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adeverse Effect, AE
Time Frame: Up to 112 days.
|
Adeverse Effect, AE
|
Up to 112 days.
|
Serious Adeverse Effect, AE
Time Frame: Up to 112 days.
|
Serious Adeverse Effect, AE
|
Up to 112 days.
|
Maximum Tolerated Dose, MTD
Time Frame: Up to 112 days.
|
Maximum Tolerated Dose, MTD
|
Up to 112 days.
|
Dose Limited Toxicity, DLT
Time Frame: Up to 112 days.
|
Dose Limited Toxicity, DLT
|
Up to 112 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-t
Time Frame: Up to 112 days.
|
AUC0-t
|
Up to 112 days.
|
Cmax
Time Frame: Up to 112 days.
|
Cmax
|
Up to 112 days.
|
AUC0-∞
Time Frame: Up to 112 days.
|
AUC0-∞
|
Up to 112 days.
|
Tmax
Time Frame: Up to 112 days.
|
Tmax
|
Up to 112 days.
|
Vd
Time Frame: Up to 112 days.
|
Vd
|
Up to 112 days.
|
Ke
Time Frame: Up to 112 days.
|
Ke
|
Up to 112 days.
|
Mean Retention Time, MRT
Time Frame: Up to 112 days.
|
Mean Retention Time, MRT
|
Up to 112 days.
|
t1/2
Time Frame: Up to 112 days.
|
t1/2
|
Up to 112 days.
|
CL
Time Frame: Up to 112 days.
|
CL
|
Up to 112 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yi Fang, Ph.D, Peking University People's Hospital
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)
November 6, 2017
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
November 24, 2019
First Submitted That Met QC Criteria
November 24, 2019
First Posted (Actual)
November 26, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GENOR GB224-001; V1.4
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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