Back to resultsClinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults
Primary Purpose
Interstitial Lung Disease
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Genakumab injection
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Safety,, Tolerability,, Pharmacokinetics,, Genakumab
Eligibility 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
Sites / Locations
- Chengdu Xinhua Hospital Affiliated to North Sichuan Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Genakumab injection
placebo
Arm Description
Group 1: 120mg，group 2: 200mg
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
Outcomes
Primary Outcome Measures
The frequency of adverse events (AE)
adverse events during the study are to assess the safety of Genakumab.
Secondary Outcome Measures
Maximum observed serum Genakumab concentration
This is to assess pharma co kinetics of Genakumab.
Area under the serum Genakumab concentration-time curve
This is to assess pharma co kinetics of Genakumab.
Full Information
NCT ID
NCT05894148
First Posted
February 27, 2023
Last Updated
June 6, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Affiliated Hospital of North Sichuan Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05894148
Brief Title
Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Affiliated Hospital of North Sichuan Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Safety,, Tolerability,, Pharmacokinetics,, Genakumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genakumab injection
Arm Type
Experimental
Arm Description
Group 1: 120mg，group 2: 200mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection
Intervention Type
Drug
Intervention Name(s)
Genakumab injection
Intervention Description
Group 1: 120mg Q4W，group 2: 200mg Q4W
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.
Primary Outcome Measure Information:
Title
The frequency of adverse events (AE)
Description
adverse events during the study are to assess the safety of Genakumab.
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Maximum observed serum Genakumab concentration
Description
This is to assess pharma co kinetics of Genakumab.
Time Frame
up to 20 weeks
Title
Area under the serum Genakumab concentration-time curve
Description
This is to assess pharma co kinetics of Genakumab.
Time Frame
up to 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ShuQin Jiang
Phone
18036617122
Email
jiangshuqin@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolan Yong, bachelor
Organizational Affiliation
Chengdu Xinhua Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ShuQin Jiang
Phone
18036617122
Email
jiangshuqin@gensci-china.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults
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