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:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04699669
Brief Summary:
The Phase 1 component of the study is a double-blind, placebo-controlled, single ascending dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD part will involve 9 proposed dosing cohorts.
Detailed Description:
The Phase 1 part of the study was a first-in-human, single ascending dose, double-blind, randomized (except Cohorts 6 to 9 \[open-label\]) study in healthy subjects to evaluate the safety, tolerability and PK of CBL-514, and to determine the dose levels to be used for the Phase 2a part of the study.
Study:
NCT04699669
Study Brief:
Protocol Section:
NCT04699669