Healthy Volunteers
Conditions
Keywords
Healthy subjects, Safety, CC-90006, Phase 1, Tolerability
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
DRUGCC-90006
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to day 105 | Number of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics- Tmax | Up to day 71 | Time to Observed maximum serum concentration |
| Pharmacokinetics- AUC0-∞ | Up to day 71 | Area under the serum concentration-time curve calculated from time zero to infinity |
| Pharmacokinetics- AUC0-t | Up to day 71 | Area under the serum concentration-time curve calculated from time zero to the last measured time point |
| Pharmacokinetics- Cmax | Up to day 71 | Observed maximum serum concentration |
| Pharmacokinetics- CL/F | Up to day 71 | Apparent clearance of drug from serum when dosed subcutaneously |
| Pharmacokinetics- Vz/F | Up to day 71 | Apparent volume of distribution when dosed subcutaneously during the terminal phase |
| Pharmacokinetics- Anti-drug antibody | Up to day 71 | A measure of the body's immune response to CC-90006 |
| Pharmacokinetics- T1/2 | Up to day 71 | Terminal half-life (T1/2) |
Countries
United States
Outcome results
None listed