Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of multiple-dose subcutaneous injections 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: Affiliated Hospital of North Sichuan Medical College

Criteria

Inclusion Criteria:

• 18 years ≤ age ≤45 years, and in good health;

• body mass index is within the range of 19 - 26 kg/m^2 (including 19 kg/m^2 and 26 kg/m^2);

• No parental scheme from the screening period to 3 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,

• Participants who use any prescription drugs within 2 weeks prior dosing.

• Participants who receive (attenuated) live vaccines within 3 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;

• 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;

• Current or previous drug or alcohol abuse;

• Other conditions in which the investigator preclude enrollment into the study