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

NCT05894148 | Completed Phase 1

• 1 other identifier: GenSci048-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Interstitial Lung Disease

Keywords

Safety,; Tolerability,; Pharmacokinetics,; Genakumab

Outcome Measures

Primary Outcomes (1)

• The frequency of adverse events (AE)

  adverse events during the study are to assess the safety of Genakumab.

  Up to 20 weeks

Secondary Outcomes (2)

• Maximum observed serum Genakumab concentration

  up to 20 weeks

• Area under the serum Genakumab concentration-time curve

  up to 20 weeks

Study Arms (2)

Genakumab injection

EXPERIMENTAL

Group 1: 120mg，group 2: 200mg

Drug: Genakumab injection

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Genakumab injection DRUG

Group 1: 120mg Q4W，group 2: 200mg Q4W

Genakumab injection

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Affiliated Hospital of North Sichuan Medical College: collaborator

Study Sites (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaolan Yong, bachelor

  Chengdu Xinhua Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: June 8, 2023
• Study Start: March 6, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)