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.

Genor Biopharma Co., Ltd.1 site in 1 country58 target enrollmentNovember 6, 2017

ConditionsRheumatoid Arthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Genor Biopharma Co., Ltd.
Enrollment: 58
Locations: 1
Primary Endpoint: Adeverse Effect, AE
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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. 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.

Registry

clinicaltrials.gov

Start Date

November 6, 2017

End Date

April 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genor Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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);