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Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers

Study Purpose

The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male volunteers. The plan is to enroll 88 healthy subjects. After signing the written informed consent voluntarily, the subjects will undergo a series of examinations and information collection to determine whether they meet the inclusion criteria. The qualified subjects will be randomized and administered. Biological samples were collected and safety checked before and after administration according to protocol requirements. Adverse events occurred during the trial were collected, and the combination of drug use and non-drug treatment were asked and recorded in detail. When the 90% confidence interval of geometric mean ratio of the main pharmacokinetic parameters of Meperizumab injection and NUCALA® was within the range of 80.00%-125.00%, it was proved that the pharmacokinetic characteristics of the two were similar.

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 - 55 Years
Gender	Male

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 1 Before the study, the informed consent was signed and the content, process and possible adverse reactions of the test were fully understood; - 2 Able to complete the research according to the requirements of the test protocol; - 3 Male subjects aged 18-55 (18 and 55 included); - 4 Body weight ≥ 50 kg ≤90 kg, body mass index (BMI) ≥ 19 ≤ 26kg/m2; - 5 Health status: No mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities; - 6 Subjects had no pregnancy plans and voluntarily used effective contraception for at least 6 months from 2 weeks prior to self-medication to their last use of study medication.

Exclusion Criteria:

- 1 Previous neuropsychiatric, respiratory, cardiovascular, digestive, hemolymph, hepatic and renal dysfunction, endocrine, skeletal and musculoskeletal disorders, or other diseases that the investigator judged might affect drug metabolism or safety; - 2 Known allergy to meperizumab or its excipients; - 3 Known history of allergic disease or allergy or history of asthma disease; - 4 Prior treatment with meperizumab or an IL-5 receptor inhibitor, or other antibody or protein drugs that target the IL-5 receptor; - 5 Who received any live viral vaccines within 2 months prior to infusion of the study drug, or who needed to be vaccinated between the screening period and the end of the study, who used the study drug within 12 months prior to administration of the study drug or planned to receive any monoclonal antibodies or biologic drugs within 12 months after administration of the study drug; - 6 Patients who have unhealed wounds, ulcers or fractures, or who underwent major surgery within 3 months prior to infusion of the study drug, or who are expected to undergo major surgery within 2 months after study completion; - 7 Any prescription, over-the-counter, vitamin product or herbal medicine used in the 2 weeks prior to taking the study drug; - 8 Abnormal and clinically significant examinations during screening period; - 9 Blood donation or significant blood loss within 3 months prior to taking the study drug (& GT; 450 ml); - 10 Participated in any drug clinical trials within 3 months prior to taking the study drug; - 11 Those who smoked more than 5 cigarettes a day 3 months before the experiment; - 12 History of alcohol abuse (14 units of alcohol per week: 1 unit =360mL beer or 45mL 40% spirits or 150mL wine); - 13 Those who are screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the three months prior to the test; - 14 Screening positive for hepatitis (including hepatitis B and C), acquired immunodeficiency syndrome(AIDS) and syphilis; - 15 The subject is unable to complete the test due to personal reasons; - 16 Conditions that other researchers consider inappropriate for inclusion

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.	NCT05353179
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.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Granulomatosis With Polyangiitis, Hemophagocytic Syndrome

Arms & Interventions

Arms

Experimental: Meperizumab injection

Subcutaneous injection of meperizumab once

Active Comparator: NUCALA®

Subcutaneous injection of NUCALA® once

Interventions

Drug: - Meperizumab injection

Meperizumab injection is a humanized monoclonal antibody of IgG1 injection

Drug: - NUCALA®

NUCALA® is a humanized monoclonal antibody of IgG1 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.