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Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects

NCT04371185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-09-13

No results posted yet for this study

Summary

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).

Conditions

Interventions

DRUG

BAT2206

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

DRUG

Stelara(US-licensed)

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

DRUG

Stelara(EU-licensed)

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Yanhua Ding · 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
2020-08-08
Primary Completion
2021-04-19
Completion
2021-04-19

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 NCT04371185 on ClinicalTrials.gov