drugset / Trial / NCT05865574

A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection

NCT05865574

Phase 1 Unknown 38 enrolled Bio-Thera Solutions
RandomizedParallel-groupDouble-blindBasic science

Summary

This is a randomized, double-blind, single-dose, parallel two-arm study to compare the pharmacokinetics, safety, and immunogenicity of BAT1706 Injection from different manufacturing batches (by new process and old process) in healthy male subjects.

Timeline

Start
2023-06
Primary completion
2023-09
Completion
2024-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT1706 Unknown 1 mg/kg Intravenous

Indications

No indication recorded.