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Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects

NCT04711343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-08-28

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 BAT2306 Injection vs Cosentyx® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 216 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 150mg BAT2306 Injection or Cosentyx® (EU-licensed and US-licensed).

Conditions

Interventions

DRUG

BAT2306

150mg/1 ml; single dose；prefilled syringe; subcutaneous injection

DRUG

Cosentyx (US-licensed)

150mg/1 ml; single dose；prefilled syringe; subcutaneous injection

DRUG

Cosentyx (EU-licensed)

150mg/1 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
2022-06-08
Primary Completion
2023-05-03
Completion
2023-06-05

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 NCT04711343 on ClinicalTrials.gov