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Completed

NCT Number: NCT05894148

Clinical Study of Multiple Dose 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genakumab injection

Drug

Group 1: 120mg Q4W,group 2: 200mg Q4W

Placebo

Drug

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

Primary outcomes

  1. The frequency of adverse events (AE)

    Time frame: Up to 20 weeks

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

Secondary outcomes

  1. Maximum observed serum Genakumab concentration

    Time frame: up to 20 weeks

    This is to assess pharma co kinetics of Genakumab.

  2. Area under the serum Genakumab concentration-time curve

    Time frame: up to 20 weeks

    This is to assess pharma co kinetics of Genakumab.

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Affiliated Hospital of North Sichuan Medical College

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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