TWB-103は、部分層皮膚移植ドナー部位の創傷を有する成人患者に有効です。

基本情報

NCT ID

NCT02737748

ステータス

完了

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

48

治験依頼者名

Transwell Biotech Co., Ltd.

概要

Primary objective: 1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding) 2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor site wounds (DSW) in terms of The healing time from DSW creation to 100% re-epithelialization Secondary objective: 1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints 2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)