Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults

Sponsor

GeneScience Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05894148

Collaborator

Afﬁliated Hospital of North Sichuan Medical College (Other)

Enrollment

Location

Arms

8.8

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	Drug: Genakumab injection Drug: placebo	Phase 1

Detailed Description

There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults

Actual Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genakumab injection Group 1: 120mg，group 2: 200mg	Drug: Genakumab injection Group 1: 120mg Q4W，group 2: 200mg Q4W
Placebo Comparator: placebo The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection	Drug: placebo The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.

Arm

Intervention/Treatment

Experimental: Genakumab injection

Group 1: 120mg，group 2: 200mg

Drug: Genakumab injection

Group 1: 120mg Q4W，group 2: 200mg Q4W

Placebo Comparator: placebo

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection

Drug: placebo

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.

Outcome Measures

Primary Outcome Measures

The frequency of adverse events (AE) [Up to 20 weeks]
adverse events during the study are to assess the safety of Genakumab.

Secondary Outcome Measures

Maximum observed serum Genakumab concentration [up to 20 weeks]
This is to assess pharma co kinetics of Genakumab.
Area under the serum Genakumab concentration-time curve [up to 20 weeks]
This is to assess pharma co kinetics of Genakumab.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years ≤ age ≤45 years, and in good health;
body mass index is within the range of 19 - 26 kg/m^{2 (including 19 kg/m}2 and 26 kg/m^2);
No parental scheme from the screening period to 3 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,
Participants who use any prescription drugs within 2 weeks prior dosing.
Participants who receive (attenuated) live vaccines within 3 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;
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;
Current or previous drug or alcohol abuse;
Other conditions in which the investigator preclude enrollment into the study