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

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894148
• Other study ID #: GenSci048-102
• Status: Recruiting
• Phase: Phase 1
• Start date: March 6, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: ShuQin Jiang
• Phone: 18036617122
• Email: jiangshuqin[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Genakumab injection
Group 1: 120mg Q4W,group 2: 200mg Q4W
• placebo
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.

Locations

Country	Name	City	State
China	Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Af?liated Hospital of North Sichuan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of adverse events (AE)	adverse events during the study are to assess the safety of Genakumab.	Up to 20 weeks
Secondary	Maximum observed serum Genakumab concentration	This is to assess pharma co kinetics of Genakumab.	up to 20 weeks
Secondary	Area under the serum Genakumab concentration-time curve	This is to assess pharma co kinetics of Genakumab.	up to 20 weeks