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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT07300202
Brief 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.
Detailed Description:
This Phase I, single-arm, open-label, dose-escalation clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers. The study aims to:
* Determine the frequency and severity of treatment-related adverse events, adverse events leading to discontinuation, and serious adverse events (SAEs) within each cohort.
* Assess the effects of Orialpha on hematology and biochemistry parameters before dosing and after the final dose in each cohort.
Healthy volunteers who meet all eligibility criteria will receive the investigational product for 7 days. The first cohort will include 3 participants receiving the lowest dose (0.25 × the anticipated clinical dose). Following safety evaluation, subsequent cohorts will receive higher dose levels (0.5 ×, 1.0 ×, 1.5 ×, and 2.0 × the anticipated clinical dose) according to predefined dose-escalation rules.
Study:
NCT07300202
Study Brief:
Protocol Section:
NCT07300202