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A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®

NCT05332730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2023-08-28

No results posted yet for this study

Summary

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

Conditions

Interventions

DRUG

BAT2506 injection

50 mg, subcutaneous administration

DRUG

Simponi® (EU commercially available product)

50 mg, subcutaneous administration

DRUG

Simponi® (US commercially available product)

50 mg, subcutaneous administration

Sponsors & Collaborators

Principal Investigators

  • Yanhua Ding, Doctor · The First Hospital of Jinlin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-06-27
Completion
2023-07-10

Countries

  • China

Study Locations

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Entities

Diseases
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 NCT05332730 on ClinicalTrials.gov