NCT05865574

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

A Randomized, Double-blind, Single-dose, Parallel Two-arm Study to Compare the Pharmacokinetics and Safety of BAT1706 Injection From Different Manufacturing Batches (by New Process and Old Process) in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

A total of 38 subjects are planned to be enrolled and randomized in a 1: 1 ratio to receive a single intravenous drip of BAT1706 Injection (by old process) or BAT1706 Injection (by new process) at 1 mg/kg body weight. A 7-day screening period will be set up for this study. Subjects will be admitted to the hospital 1 day pre-dose (Day -1) and discharged after completing relevant observations and assessments 24 h post-dose. After discharge, subjects should return to the hospital for 12 follow-up visits according to the requirements of this study, on Days 3, 4, 5, 8, 11, 15, 22, 29, 36, 43, 57 and 71 post-dose.

Conditions

• Healthy Men

Interventions

Type	Name	Description
DRUG	BAT1706 Injection	1 vial/carton, 400 mg/16 mL/vial

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-09-01
• Completion: 2024-01-01
• First posted: 2023-05-19
• Last updated: 2023-05-19

Locations

1 site across 1 country: China