A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
NCT ID: NCT02934269
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2016-11-21
2017-08-15
Brief Summary
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Detailed Description
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This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40 subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8 subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2 subjects).
Eligible subjects will check into the clinic site on the day before dosing (Day -1) and receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2), 22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be performed and blood samples will be collected for determination of levels of CC-90006 in the blood.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CC-90006; Dose Level 1
CC-90006 will be administered by subcutaneous injection in the abdomen
CC-90006
CC-90006; Dose Level 2
CC-90006 will be administered by subcutaneous injection in the abdomen
CC-90006
CC-90006; Dose Level 3
CC-90006 will be administered by subcutaneous injection in the abdomen
CC-90006
CC-90006; Dose Level 4
CC-90006 will be administered by subcutaneous injection in the abdomen
CC-90006
CC-90006; Dose Level 5
CC-90006 will be administered by subcutaneous injection in the abdomen
CC-90006
Placebo
Placebo will be administered by subcutaneous injection in the abdomen
Placebo
Interventions
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Placebo
CC-90006
Eligibility Criteria
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Inclusion Criteria
* Females must have been surgically sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening).
Exclusion Criteria
* Donation blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.
* History of alcohol or drug abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol or drug screen.
* Vaccination within 30 days prior to the first dose administration or has plans to receive a vaccination during the course of the study (including the follow phone call on Day 105).
18 Years
55 Years
ALL
Yes
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Leon Carayannopoulos, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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PPD Phase 1 Unit
Austin, Texas, United States
Countries
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Other Identifiers
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CC-90006-CP-001
Identifier Type: -
Identifier Source: org_study_id
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