Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers
Phase 1
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Drug: Placebo for this trial
- Registration Number
- NCT04337437
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genakumab injection：5 groups Genakumab 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, Placebo for this trial : 5 groups Placebo for this trial 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,
- Primary Outcome Measures
Name Time Method Maximum observed serum Genakumab concentration 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 Area under the serum Genakumab concentration-time curve 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 Measurement of the serum IL-1β for pharmacodynamics study 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 Measures
Name Time Method The frequency of adverse events (AE) From screening to follow-up period (up to day 22)
Trial Locations
- Locations (1)
Clinical Pharmacology Research Center of Peking Union Medical College Hospital
🇨🇳Beijing, China