Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

• Sponsor: GeneScience Pharmaceuticals Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04337437
• Collaborator: Peking Union Medical College Hospital (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.4
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis	Drug: Genakumab; Drug: Placebo for this trial	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind (participant, investigator), excluding one non-blind investigator doctor.
• Primary Purpose: Other
• Official Title: The Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Genakumab for Injection in Chinese Healthy Volunteers
• Actual Study Start Date: Apr 22, 2019
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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

1. The frequency of adverse events (AE) [From screening to follow-up period (up to day 22)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology Research Center of Peking Union Medical College Hospital	Beijing		China

Sponsors and Collaborators

• GeneScience Pharmaceuticals Co., Ltd.
• Peking Union Medical College Hospital

Investigators

• Principal Investigator: Rui Chen, Clinical Pharmacology Research Center of Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04337437
• Other Study ID Numbers: GenSci 048-I CT
• First Posted: Apr 7, 2020
• Last Update Posted: Apr 7, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis, Juvenile

Study Results

No Results Posted as of Apr 7, 2020