drugset / Trial / NCT05108259
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-03-30
- Primary completion
- 2026-02
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | PBP1502 | Unknown | 40 mg | Subcutaneous |
Indications
No indication recorded.