Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers
Status:
Not yet recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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.