Clinical trial NCT04337437: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2020-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Maximum observed serum Genakumab concentration
timeFrame: 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
measure: Area under the serum Genakumab concentration-time curve
timeFrame: 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
measure: Measurement of the serum IL-1β for pharmacodynamics study
timeFrame: 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 outcomes:
measure: The frequency of adverse events (AE)
timeFrame: From screening to follow-up period (up to day 22)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical Pharmacology Research Center of Peking Union Medical College Hospital
Study officials:
affiliation: Clinical Pharmacology Research Center of Peking Union Medical College Hospital
name: Rui Chen
role: PRINCIPAL_INVESTIGATOR
References: