Back to resultsClinical Study of Genakumab for Injection in Chinese Healthy Volunteers
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Genakumab
Placebo for this trial
Sponsored by
About this trial
This is an interventional other trial for Juvenile Idiopathic Arthritis
Eligibility Criteria
Inclusion Criteria:
- 18 years ≤ age ≤50 years, and in good health;
- 40kg ≤ weight ≤100kg , and body mass index is within the range of 18 - 28 kg/m^2 (including 18 kg/m^2 and 28 kg/m^2);
- No parental scheme from the screening period to 6 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, acute or chronic bronchospastic disease;
- Smoking more than 5 cigarettes per day;
- Participants who use any prescription drugs within 4 weeks prior dosing, or over-the-counter medication within 2 weeks prior to dosing. Participants who receive treatment of any biologics within three months prior to dosing. Participants who receive (attenuated) live vaccines within six 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; donation or loss of 200 mL or more of blood within 4 weeks prior to dosing; or donation of component blood within 2 weeks 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;
- Clinically significant acute infection within 2 weeks prior to dosing;
- Current or previous drug or alcohol abuse;
- Other conditions in which the investigator preclude enrollment into the study.
Sites / Locations
- Clinical Pharmacology Research Center of Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Genakumab injection：5 groups
Placebo for this trial : 5 groups
Arm Description
150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D：4mg/kg, Group E : 6mg/kg,
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D：4mg/kg, Group E : 6mg/kg,
Outcomes
Primary Outcome Measures
Maximum observed serum Genakumab concentration
Area under the serum Genakumab concentration-time curve
Measurement of the serum IL-1β for pharmacodynamics study
Secondary Outcome Measures
The frequency of adverse events (AE)
Full Information
NCT ID
NCT04337437
First Posted
April 1, 2020
Last Updated
April 3, 2020
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04337437
Brief Title
Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers
Official Title
The Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Genakumab for Injection in Chinese Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking Union Medical College Hospital
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 single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers
Detailed Description
There are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group.
Since the strength of experimental drug is 150mg/1ml/ bottle, participants with a single dose of more than 150mg need to be given subcutaneously at different sites in two or more times
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind (participant, investigator), excluding one non-blind investigator doctor.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genakumab injection：5 groups
Arm Type
Experimental
Arm Description
150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D：4mg/kg, Group E : 6mg/kg,
Arm Title
Placebo for this trial : 5 groups
Arm Type
Placebo Comparator
Arm Description
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.
Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D：4mg/kg, Group E : 6mg/kg,
Intervention Type
Drug
Intervention Name(s)
Genakumab
Intervention Description
150 mg/1ml/bottle, single subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo for this trial
Intervention Description
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.
Primary Outcome Measure Information:
Title
Maximum observed serum Genakumab concentration
Time Frame
Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
Title
Area under the serum Genakumab concentration-time curve
Time Frame
Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
Title
Measurement of the serum IL-1β for pharmacodynamics study
Time Frame
Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
Secondary Outcome Measure Information:
Title
The frequency of adverse events (AE)
Time Frame
From screening to follow-up period (up to day 22)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years ≤ age ≤50 years, and in good health;
40kg ≤ weight ≤100kg , and body mass index is within the range of 18 - 28 kg/m^2 (including 18 kg/m^2 and 28 kg/m^2);
No parental scheme from the screening period to 6 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, acute or chronic bronchospastic disease;
Smoking more than 5 cigarettes per day;
Participants who use any prescription drugs within 4 weeks prior dosing, or over-the-counter medication within 2 weeks prior to dosing. Participants who receive treatment of any biologics within three months prior to dosing. Participants who receive (attenuated) live vaccines within six 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; donation or loss of 200 mL or more of blood within 4 weeks prior to dosing; or donation of component blood within 2 weeks 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;
Clinically significant acute infection within 2 weeks prior to dosing;
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
Luocheng Xu
Phone
800-820-0469
Email
xuluocheng@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Chen
Organizational Affiliation
Clinical Pharmacology Research Center of Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Pharmacology Research Center of Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Chen
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers
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