Glatt Pharmaceutical Services Gmbh & Co Kg

Ⅰ 期，A 部分 - 剂量递增： - 确定 CB-103 单药治疗成年患者的最大耐受剂量（MTD）或推荐的 Ⅱ 期剂量 （RP2D）。 Ⅰ 期，A 部分 - 确证性队列： - 确认 CB-103 单药治疗成年患者的 RP2D 的安全性。 ⅡA 期，B 部分 - 剂量扩展： - 评估 CB-103 单药在不同适应症的不同扩展组中的初步抗肿瘤活性。

这项研究旨在评估 BAY 1817080 相较于 elagolix 和安慰剂在症状性子宫内膜异位症女性中的安全性和有效性。研究详情包括：研究持续时间：155天至285天，治疗持续时间：84天，访视频率：约每月一次

Glatt Pharmaceutical Services GmbH & Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions.
The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.