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COMPLETED
NCT05865574
PHASE1

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

Sponsor: Bio-Thera Solutions

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2023-06-15

Completion Date

2024-01-03

Last Updated

2026-10-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BAT1706 Injection

1 vial/carton, 400 mg/16 mL/vial

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China