Status:
UNKNOWN
Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers
Detailed Description
There are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group. Since the strength of experimental drug ...
Eligibility Criteria
Inclusion
- 18 years ≤ age ≤50 years, and in good health;
- 40kg ≤ weight ≤100kg , and body mass index is within the range of 18 - 28 kg/m\^2 (including 18 kg/m\^2 and 28 kg/m\^2);
- No parental scheme from the screening period to 6 months after the study period.
Exclusion
- Participants have abnormal physical and auxiliary examination results with clinical significance;
- History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders, acute or chronic bronchospastic disease;
- Smoking more than 5 cigarettes per day;
- Participants who use any prescription drugs within 4 weeks prior dosing, or over-the-counter medication within 2 weeks prior to dosing. Participants who receive treatment of any biologics within three months prior to dosing. Participants who receive (attenuated) live vaccines within six months prior to dosing;
- Participation in any clinical investigation within 3 months prior to dosing;
- Donation or loss of 400 mL or more of blood within 3 months prior to dosing; donation or loss of 200 mL or more of blood within 4 weeks prior to dosing; or donation of component blood within 2 weeks prior to dosing;
- Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
- Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
- Clinically significant acute infection within 2 weeks prior to dosing;
- Current or previous drug or alcohol abuse;
- Other conditions in which the investigator preclude enrollment into the study.
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04337437
Start Date
April 22 2019
End Date
September 1 2020
Last Update
April 7 2020
Active Locations (1)
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1
Clinical Pharmacology Research Center of Peking Union Medical College Hospital
Beijing, China