Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

The Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Genakumab for Injection in Chinese Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337437
• Other study ID #: GenSci 048-I CT
• Status: Recruiting
• Phase: Phase 1
• Start date: April 22, 2019
• Est. completion date: September 2020

Study information

• Verified date: March 2020
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Luocheng Xu
• Phone: 800-820-0469
• Email: xuluocheng[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Genakumab
150 mg/1ml/bottle, single subcutaneous injection.
• 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.

Locations

Country	Name	City	State
China	Clinical Pharmacology Research Center of Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Measurement of the serum IL-1ß 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	The frequency of adverse events (AE)		From screening to follow-up period (up to day 22)