Overview

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