NCT06886659View on ClinicalTrials.gov

A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 23, 2024

Primary Completion Date

December 28, 2024

Study Completion Date

December 28, 2024

Conditions
Breast CancerBreast NeoplasmsBreast DiseaseAntineoplastic Agents
Interventions
DRUG

Trastuzumab (proposed Trastuzumab biosimilar)

6 mg/kg single intravenous infusion of Trastuzumab of Incepta Pharmaceuticals Ltd

DRUG

Herclon

6 mg/kg single intravenous infusion of Trastuzumab of Roche

Trial Locations (2)

1207

Al-Manar Hospital Ltd,, Dhaka

1215

Universal Medical College, Dhaka

Sponsors
All Listed Sponsors
collaborator

EskeGen Ltd, Bangladesh

UNKNOWN

lead

Incepta Pharmaceuticals Ltd

INDUSTRY