A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
- Registration Number
- NCT02934269
- Lead Sponsor
- Celgene
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CC-90006; Dose Level 3 CC-90006 CC-90006 will be administered by subcutaneous injection in the abdomen CC-90006; Dose Level 4 CC-90006 CC-90006 will be administered by subcutaneous injection in the abdomen CC-90006; Dose Level 2 CC-90006 CC-90006 will be administered by subcutaneous injection in the abdomen Placebo Placebo Placebo will be administered by subcutaneous injection in the abdomen CC-90006; Dose Level 5 CC-90006 CC-90006 will be administered by subcutaneous injection in the abdomen CC-90006; Dose Level 1 CC-90006 CC-90006 will be administered by subcutaneous injection in the abdomen
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) Up to day 105 Number of participants with adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics- Cmax Up to day 71 Observed maximum serum concentration
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- T1/2 Up to day 71 Terminal half-life (T1/2)
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
Trial Locations
- Locations (1)
PPD Phase 1 Unit
🇺🇸Austin, Texas, United States