A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 2/10/2018 |
Start Date: | November 21, 2016 |
End Date: | August 15, 2017 |
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled study to evaluate the safety,
tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following
administration of single subcutaneous doses in healthy subjects.
tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following
administration of single subcutaneous doses in healthy subjects.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic
profile of single-ascending doses of CC-90006 in healthy subjects.
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.
profile of single-ascending doses of CC-90006 in healthy subjects.
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.
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, and a body
mass index (BMI) of ≥ 18 and ≤ 33 kg/m2 with body weight ≥ 50 and ≤ 90 kg at
screening.
- 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:
- Exposure/treatment to an investigational (new chemical entity) or marketed drug or
biologic within 30 days preceding the first dose administration, or five half-lives of
that investigational drug or biologic, if known (whichever is longer).
- 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).
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