NCT05108259

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

A Phase 1, Double-blind, Randomized, Three-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®, and US-Humira® in Healthy Male and Female Subjects.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Prestige Biopharma Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single centre, randomized, double-blind, three-arm, parallel group, single-dose, active comparator study, where a total of 324 healthy male and female adult volunteers - between the age of 18 and 55 years, both inclusive - will be dosed; 108 subjects per treatment group, randomly assigned to one of the 3 treatment arms.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-30
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2021-11-04
• Last updated: 2025-05-31

Locations

1 site across 1 country: Spain