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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 1

Conditions: Interstitial Lung Disease

Treatments: Drug: Genakumab injection; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05894148

GenSci048-102

Details and patient eligibility

About

To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.

Full description

There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Genakumab injection

Experimental group

Description:

Group 1: 120mg，group 2: 200mg

Treatment:

Drug: Genakumab injection

placebo

Placebo Comparator group

Description:

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Treatment:

Drug: placebo