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

Brief Title

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

Official Title

Phase I, Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of Pharmacokinetic and Safety Similarities Between Meperizumab Injection and NUCALA® in Healthy Male Volunteers

Brief Summary

      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.
    

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Peak concentration(Cmax)

Secondary Outcome

 The area under the curve extrapolating from zero to infinity(AUC0-∞)

Condition

Granulomatosis With Polyangiitis

Intervention

Meperizumab injection

Study Arms / Comparison Groups

 Meperizumab injection

Description:  Subcutaneous injection of meperizumab once

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

88

Start Date

June 2022

Completion Date

October 2022

Primary Completion Date

October 2022

Eligibility 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
      

Gender

Male

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 0431-86177635, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT05353179

Organization ID

TQC3566-I-01

Responsible Party

Sponsor

Study Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Sponsor

, , 

Verification Date

April 2022