3-part Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Multiple Doses of CC-220 and Relative Bioavailability of a Formulated CC-220 Capsule
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses
      of CC-220 in healthy subjects and to evaluate the relative bioavailability of a formulated
      CC-220 capsule
    

Detailed description: 
      This is a 3-part study to be conducted at a single study center. Part 1 is a randomized,
      double-blind, placebo-controlled, ascending-dose study. 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 4 cohorts, each of which consists of a different
      dose level and/or dosing duration, with 8 or 9 subjects per cohort. In each cohort, 6
      subjects will receive a dose of CC-220 and the remaining subjects will receive placebo
      depending on the randomization schedule. In 2 of the cohorts, study drug will be administered
      once daily for a total of 14 days. In the other 2 cohorts, study drug will be administered
      once daily for 28 days. In one of the 28-day dosing cohorts, 2 vaccinations (tetanus toxoid
      adsorbed and pneumococcal vaccinations) will also be administered on Day 14 of the 28-day
      dosing period to help characterize the effect of CC-220 on antibody responses. Part 2 is a
      randomized, double-blind, placebo-controlled, parallel-group study to explore the effects of
      an alternative dosing schedule on the pharmacodynamics of CC-220. 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 2 cohorts, each of which consists of a
      different dose level, with 9 subjects per cohort. In each cohort, 6 subjects will receive a
      dose of CC-220 and 3 subjects will receive placebo depending on the randomization schedule.
      The dosing frequency will be either once every 3 days for 14 days or once every 7 days for 28
      days. Part 3 is a randomized, open-label, two-period, two-way crossover study to evaluate the
      relative bioavailability of one CC-220 formulated capsule, relative to two reference
      capsules, following a single oral dose of CC-220. During the course of Part 3, each subject
      will participate in a screening phase, a baseline phase, a treatment phase consisting of 2
      periods, and a follow up visit. There will be one cohort consisting of a total of 12
      subjects. In each study period, approximately 6 subjects will receive a single dose of CC-220
      as one formulated capsule (test product) and approximately 6 subjects will receive a single
      dose of CC-220 as two reference capsules (reference product).
    

Intervention name(s): CC-220; CC-220; CC-220; CC-220; Placebo; CC-220; CC-220; CC-220
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): CC-220 0.3mg will be administered once daily for 14 days; CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination; CC-220 0.3mg will be administered once daily for 28 days; CC-220 1mg will be administered once daily for 7 days on 2 separate occasions, with a 7-day washout in between, for a total of 14 days of dosing; Placebo will be administered once daily for up to 28 days; CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses); CC-220 1mg (once every 7 days for 28 days); CC-220 1mg will be administered as a single dose in each of 2 study periods; once as a formulated capsule and once as two reference capsules
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety, Pharmacokinetics, Pharmacodynamics, Healthy Subjects