drugset / Trial / NCT05863442

Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants

NCT05863442

Phase 1 Unknown 120 enrolled Turgut Ardika PTY LTD
RandomizedParallel-groupDouble-blindBasic science

Summary

This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.

Timeline

Start
2023-04-10
Primary completion
2024-07-23
Completion
2024-10-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Eculizumab Monoclonal antibody 300 mg Intravenous
Subject TUR03 Unknown 300 mg Intravenous

Indications

No indication recorded.