A Comparative Evaluation of Pharmacokinetics and Immunogenicity.

Summary

The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects. Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment. Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.

Timeline

Start

2024-09-05

Primary completion

2025-05-25

Completion

2025-05-25

Drugs

Indications