Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

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

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

Study Overview

• Status: Unknown
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Drug: Genakumab; Drug: Placebo for this trial

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Clinical Pharmacology Research Center of Peking Union Medical College Hospital
    • Contact: Rui Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genakumab injection：5 groups; 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,	Drug: Genakumab; 150 mg/1ml/bottle, single subcutaneous injection.
Placebo Comparator: Placebo for this trial : 5 groups; 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,	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
The frequency of adverse events (AE)	From screening to follow-up period (up to day 22)

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Rui Chen, Clinical Pharmacology Research Center of Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: GenSci 048-I CT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No