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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 45 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05894148
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Changchun GeneScience Pharmaceutical Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Xiaolan Yong, bachelor
Principal Investigator Affiliation	Chengdu Xinhua Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Additional Details

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.

Arms & Interventions

Arms

Experimental: Genakumab injection

Group 1: 120mg，group 2: 200mg

Placebo Comparator: placebo

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

Interventions

Drug: - Genakumab injection

Group 1: 120mg Q4W，group 2: 200mg Q4W

Drug: - placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.