drugset / Trial / NCT03239379

A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects

NCT03239379 ↗

Phase 1 Completed 32 enrolled Bioniz Therapeutics Celerion · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be enrolled in the trial. Participants will be followed for 4 weeks after the last dose for safety monitoring, and collection of PK and PD samples.

Timeline

Start
2017-10-30
Primary completion
2018-02-15
Completion
2018-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject BNZ132-1-40 Peptide — Intravenous

Indications

No indication recorded.