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

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

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Drug: Genakumab injection
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genakumab injection<br>Group 1: 120mg，group 2: 200mg | Drug: Genakumab injection<br>* Group 1: 120mg Q4W，group 2: 200mg Q4W<br>|
| Placebo Comparator: placebo<br>The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection | Drug: placebo<br>* The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of adverse events (AE) | adverse events during the study are to assess the safety of Genakumab. | Up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum Genakumab concentration | This is to assess pharma co kinetics of Genakumab. | up to 20 weeks | 
| Area under the serum Genakumab concentration-time curve | This is to assess pharma co kinetics of Genakumab. | up to 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety,, Tolerability,, Pharmacokinetics,, Genakumab