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

NCT05108259 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

PBP1502

40 mg/0.4 mL single SC injection via PFS

DRUG

EU-licensed Humira

40 mg/0.4 mL single SC injection via PFS

DRUG

US-licensed Humira

40 mg/0.4 mL single SC injection via PFS

Sponsors & Collaborators

  • Prestige Biopharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2026-02-28
Completion
2026-05-31

Countries

  • Spain

Study Locations

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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 NCT05108259 on ClinicalTrials.gov