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

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

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

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Drug: Genakumab injection; Drug: placebo

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: shuqin jiang; Phone Number: 18036617122; Email: jiangshuqin@gensci-china.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
      • Contact: shuqin jiang; Phone Number: 18036617122; Email: jiangshuqin@gensci-china.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of adverse events (AE)	adverse events during the study are to assess the safety of Genakumab.	Up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed serum Genakumab concentration	This is to assess pharma co kinetics of Genakumab.	up to 20 weeks
Area under the serum Genakumab concentration-time curve	This is to assess pharma co kinetics of Genakumab.	up to 20 weeks

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Affiliated Hospital of North Sichuan Medical College
• Investigators: Study Chair: Xiaolan Yong, bachelor, Chengdu Xinhua Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Safety,; Pharmacokinetics,; Tolerability,; Genakumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: GenSci048-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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