To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects

Sponsor
Prestige Biopharma Limited
Study ID
NCT05108259
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • PBP1502 — DRUG
    40 mg/0.4 mL single SC injection via PFS
  • EU-licensed Humira — DRUG
    40 mg/0.4 mL single SC injection via PFS
  • US-licensed Humira — DRUG
    40 mg/0.4 mL single SC injection via PFS

Study Details

The main purpose of the study is to demonstrate pharmacokinetic (PK) equivalence of PBP1502 to the European (EU) and American (US) Humira reference products, following a single subcutaneous (SC) dose of 40 mg in healthy volunteers.

Key Dates

Start date
Mar 30, 2022
Status verified
May 2025
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PBP1502
    Adalimumab single dose 40 mg (100 mg/mL) by SC injection via pre-filled syringe (PFS)
  • Active Comparator: EU-licensed Humira
    Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS
  • Active Comparator: US-licensed Humira
    Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS

Primary Outcome Measure

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) [ Time Frame: Up to Day 71 ]

Central Contacts

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