drugset / Trial / NCT05197179

A Bridging Study of FB2001 in Healthy Subjects

NCT05197179 ↗

Phase 1 Completed 40 enrolled Frontier Biotechnologies Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed,and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing.

Timeline

Start
2021-12-29
Primary completion
2022-04-27
Completion
2022-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject FB2001 Small molecule — Intravenous

Indications