This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).
- Sponsor
- Biocon Biologics UK Ltd
- Study ID
- NCT06738277
- Phase
- PHASE1
- Status
- Completed
Conditions
- Moderate to Severe Chronic Plaque Psoriasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Bmab 1200 (Biosimilar Ustekinumab) — DRUGDosage Form: injection, Strength(s): 45 mg/ 0.5 mL Route of Administration: Subcutaneous Frequency and Dose: 45 mg, single dose
Study Details
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS).
Key Dates
- Start date
- Jan 9, 2025
- Status verified
- Aug 2025
- Primary completion
- Jul 12, 2025
- Completion
- Jul 12, 2025
Study Design
- Enrollment
- 186 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Bmab 1200 AI (Biosimilar Ustekinumab)
- Active Comparator: Bmab 1200 PFS (Biosimilar Ustekinumab)
Primary Outcome Measure
Cmax [ Time Frame: Week 16 ]