A Phase 1, Randomized, Three-Arm, Double-Blind, Single Dose Study to Compare the Safety and Pharmacokinetics of the Potential Biosimilar NeuCeptin with Trastuzumab in Healthy Male Volunteers
Status: Active, no longer recruiting
Phase of Trial: Phase I
Latest Information Update: 05 Dec 2019
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At a glance
- Drugs Trastuzumab (Primary)
- Indications Breast cancer; Cancer; Gastric cancer
- Focus First in man; Pharmacokinetics
- Sponsors NeuClone
- 05 Dec 2019 Results presented in the NeuClone media release.
- 05 Dec 2019 Primary endpoint (To assess if NeuCeptin administered intravenously (IV) to healthy adult male subjects is comparable to Herceptin (EU and/or US) in area under the concentration-time curve (AUC) from time 0 to last quantifiable concentration (AUC0-last), AUC from time 0 extrapolated to infinity (AUC0-8), and maximum plasma concentration (Cmax) (ie, within 80.00% to 125.00% for all 3 pairwise comparisons), up...) has been met, according to a NeuClone media release.
- 21 Oct 2019 Planned End Date changed from 8 Feb 2019 to 30 Nov 2019.