First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): CC-90001; CC-90001; CC-90001; CC-90001; CC-90001; CC-90001; CC-90001; CC-90001; CC-90001; CC-90001; Placebo; CC-90001; CC-90001; CC-90001
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): CC-90001 10mg will be administered as a single dose; CC-90001 30mg will be administered as a single dose; CC-90001 60mg will be administered as a single dose; CC-90001 120mg will be administered as a single dose; CC-90001 240mg will be administered as a single dose; CC-90001 10mg will be administered daily for 14 days; CC-90001 30mg will be administered daily for 14 days; CC-90001 60mg will be administered daily for 14 days; CC-90001 120mg will be administered daily for 14 days; CC-90001 240mg will be administered daily for 14 days; Placebo will be administered once daily for up to 14 days depending on the Part of the study; CC-90001 480mg will be administered as a single oral dose; CC-90001 720mg will be administered as a single oral dose; CC-90001 480mg will be administered daily for 14 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety; Pharmacokinetics; Healthy Subjects; First-in-Human