Trial intelligence / Profile preview

PK, Immunogenicity and Safety of Incepta's Trastuzumab vs Herclon in Healthy Men

NCT06886659Phase 1Completed

Sponsor
Incepta Pharmaceuticals Ltd.
Start
Jan 2024
Primary completion
Dec 2024
Modality
Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
Countries
1
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Overview

Phase 1, randomised, double-blind trial of trastuzumab in breast cancer, gastric cancer (GC) and gastroesophageal junction cancer (2 arms), sponsored by Incepta Pharmaceuticals Ltd. Primary endpoints: Maximum Plasma Concentration at 71 days, Area Under the Concentration-Time Curve from time zero to last measurable concentration at 71 days and 3 more. Started Jan 2024; status: completed.

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Drugs

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Conditions

breast cancergastric cancer (GC)gastroesophageal junction cancer

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