Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

• Status: Recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborator: Peking Union Medical College Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.