Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

GeneScience Pharmaceuticals (GenSci)

Status and phase: Unknown; Phase 1

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: Placebo for this trial; Drug: Genakumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04337437

GenSci 048-I CT

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Genakumab injection：5 groups

Experimental group

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,

Treatment:

Drug: Genakumab

Placebo for this trial : 5 groups

Placebo Comparator group

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,

Treatment:

Drug: Placebo for this trial