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

Phase 1

Completed

• Conditions: Interstitial Lung Disease
• Interventions: Drug: Genakumab injection; Drug: placebo

• Registration Number: NCT05894148
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-02-27
• Study Start: 2023-03-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-08
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College; 🇨🇳 Chengdu, Sichuan, China