NCT05353179

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Granulomatosis With Polyangiitis
• Hemophagocytic Syndrome

Interventions

Type	Name	Description
DRUG	Meperizumab injection	Meperizumab injection is a humanized monoclonal antibody of IgG1 injection
DRUG	NUCALA®	NUCALA® is a humanized monoclonal antibody of IgG1 injection

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: China