A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers

Phase 1 Completed 15 enrolled Oriplantee Company Limited Vietstar Biomedical Research · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase I clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers.

Timeline

Start: 2025-02-13
Primary completion: 2025-06-16
Completion: 2025-08-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Orialpha	Unknown	1.5 g	Oral
Subject	Orialpha	Unknown	3 g	Oral
Subject	Orialpha	Unknown	4.5 g	Oral
Subject	Orialpha	Unknown	6 g	Oral

A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers

Summary

Timeline

Drugs

Indications