Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT03642834
Brief Summary:
Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.
Detailed Description:
The study consisted of a screening period, a treatment period with repeated 28-day treatment cycles (duration treatment with ICP-105), and a follow-up period (within 30 days of the last dose and post-treatment follow-up 30 days after the last visit). The recruited patients receive a single dose on day 1, then after a 3-day washout period, multiple dosing will be initiated following dose-escalation schedule. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (28-day cycle).
Study:
NCT03642834
Study Brief:
Protocol Section:
NCT03642834