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A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects

Healthy Adult Subjects Clinical Trial

Official title:
A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects

Clinical Trial Summary

This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.

Clinical Trial Description

A total of 324 healthy subjects are planned to be enrolled and randomized into 3 groups at a ratio of 1:1:1, with 108 subjects in each group. They will receive 2 doses of the test drug T1 (CBP-201 injection (pre-filled syringe, 150 mg/1 mL)), 1 dose of the test drug T2 (CBP-201 injection (pre-filled syringe, 300 mg/2 mL)), and 2 doses of the reference drug R (CBP-201 injection (vial, 150 mg/1 mL)), respectively. The study consists of a screening period (Day-28 to Day-2), a baseline period (Day-1), an administration and observation period (Day1 to Day6), and a follow-up period (Day7 to Day57). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05917782
Study type Interventional
Source Suzhou Connect Biopharmaceuticals, Ltd.
Contact
Status Completed
Phase Phase 1
Start date July 18, 2023
Completion date October 6, 2023
View Details
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