MedTrace Logo

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

NCT05968508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-29

No results posted yet for this study

Summary

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

Conditions

  • Healthy Men

Interventions

DRUG

BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)

A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.

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
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2024-10-08
Completion
2024-10-08

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 NCT05968508 on ClinicalTrials.gov