Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Phase 1 Completed 91 enrolled Boehringer Ingelheim

RandomizedParallel-groupSingle-blindTreatment

Summary

This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.

Timeline

Start: 2012-05-01
Primary completion: 2012-11-01
Completion: 2012-11-01

Outcome

Met primary endpoint

paper The interim analysis demonstrated three-way bioequivalence for all comparisons. PMID 28651442 ↗

registry analysis (equivalence test); BI 695502 (T) vs United States (US)-Licensed Avastin® (R1); gMean ratio 96.58 (93.93% CI 88.54 to 105.35); ANOVA NCT01608087 ↗

registry analysis (equivalence test); BI 695502 (T) vs European Union (EU)-Approved Avastin® (R2); gMean ratio 91.68 (93.93% CI 83.50 to 100.65); ANOVA NCT01608087 ↗

release “BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN®-1 study.” prnewswire.com ↗

Publications

Hettema W, Wynne C, Lang B, Altendorfer M, Czeloth N, Lohmann R, Athalye S, Schliephake D. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. Expert Opin Investig Drugs. 2017 Aug;26(8):889-896. doi: 10.1080/13543784.2017.1347635. Epub 2017 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 695502	Unknown	1 mg/kg	Intravenous
Comparator	Bevacizumab	Monoclonal antibody	1 mg/kg	Intravenous

Indications

No indication recorded.