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

NCT05865574 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-05-19

No results posted yet for this study

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.

Conditions

  • Healthy Men

Interventions

DRUG

BAT1706 Injection

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

Sponsors & Collaborators

Principal Investigators

  • Wei Hu, Ph.D · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-09-30
Completion
2024-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865574 on ClinicalTrials.gov