NCT03912441

First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects

Open-label Non-Comparator Multicohort Trial of Pharmacokinetics, Safety And Immunogenicity of BCD-147 (JSC "BIOCAD", Russia) After Single Administration of Escalating Doses in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	BCD-147	Bispecific anti-HER2 monoclonal antibody

Timeline

• Start date: 2019-01-30
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2019-04-11
• Last updated: 2020-09-18

Locations

1 site across 1 country: Russia