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

Sponsor
Bio-Thera Solutions
Study ID
NCT04711343
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BAT2306 — DRUG
    150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
  • Cosentyx (US-licensed) — DRUG
    150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
  • Cosentyx (EU-licensed) — DRUG
    150mg/1 ml; single dose；prefilled syringe; subcutaneous injection

Study Details

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).

Key Dates

Start date
Jun 8, 2022
Status verified
Aug 2023
Primary completion
May 3, 2023
Completion
Jun 5, 2023

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAT2306 injection
    150mg /1ml; subcutaneous injection
  • Active Comparator: Cosentyx (US-licensed)
    150mg /1ml; subcutaneous injection
  • Active Comparator: Cosentyx (EU-licensed)
    150mg /1ml; subcutaneous injection

Primary Outcome Measure

Pharmacokinetics Endpoint：Peak plasma concentration (Cmax) [ Time Frame: 0-5months ]

Related Studies