A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection

NCT05203289 ↗

Phase 1 Completed 200 enrolled Boehringer Ingelheim

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.

Timeline

Start: 2022-02-18
Primary completion: 2022-08-29
Completion: 2022-08-29

Publications

Moschetti V, Buschke S, Bertulis J, Hohl K, McCabe D. Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF). Expert Opin Biol Ther. 2024 Jul;24(7):673-679. doi: 10.1080/14712598.2024.2354902. Epub 2024 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 695501	Monoclonal antibody	40 mg	Subcutaneous

Indications

No indication recorded.