NCT06738277

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).

A Phase 1, Randomized, Open-label, 2-arm, Parallel Design Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, and Tolerability of Bmab 1200 -Autoinjector (Biosimilar Ustekinumab) After Single Subcutaneous Injection in Comparison With Bmab 1200 -Prefilled Syringe (Biosimilar Ustekinumab)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Biocon Biologics UK Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

Bmab 1200 is being developed as a proposed biosimilar product to the reference product Stelara® in accordance with EU and US biosimilar guidelines. The currently available Bmab 1200 formulation is administered via SC injection using PFS (similar to the reference product Stelara®). The main purpose of this study is to establish the PK equivalence of Bmab 1200 -AI following a single SC injection ( 45 mg) in comparison with Bmab 1200 -PFS. AI and PFS are self-injectable devices that can deliver drugs through the SC route. This study will also assess the safety and tolerability of Bmab 1200 AI in comparison with Bmab 1200 PFS. This will enable the licensure of AI to improve patient compliance through controlled and standardized administration of Bmab 1200

Conditions

• Moderate to Severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Bmab 1200 (Biosimilar Ustekinumab)	Dosage Form: injection, Strength(s): 45 mg/ 0.5 mL Route of Administration: Subcutaneous Frequency and Dose: 45 mg, single dose

Timeline

• Start date: 2025-01-09
• Primary completion: 2025-07-12
• Completion: 2025-07-12
• First posted: 2024-12-17
• Last updated: 2025-08-19

Locations

1 site across 1 country: India