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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT02110420
Brief Summary:
First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001
Detailed Description:
This is a 2-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 7 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following multiple oral doses in healthy subjects. Only doses that are safe and well tolerated in Part 1 will be administered in Part 2. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of up to 6 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered once daily for up to 14 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1; however, the maximum dose administered in Part 2 will not exceed the maximum tolerated dose in Part 1.
Study:
NCT02110420
Study Brief:
Protocol Section:
NCT02110420