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

Granulomatosis With Polyangiitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05353179
Study type Interventional
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Haimiao Yang, Master
Phone 0431-86177635
Email czfyyq728@163.com
Status Not yet recruiting
Phase Early Phase 1
Start date June 2022
Completion date October 2022
View Details
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