Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
Study NCT ID:
NCT05108259
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2021-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
Sponsor:
Prestige Biopharma Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: