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
Overview
- Phase
- Phase 1
- Intervention
- CC-90006
- Conditions
- Healthy Volunteers
- Sponsor
- Celgene
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
CC-90006; Dose Level 1
CC-90006 will be administered by subcutaneous injection in the abdomen
Intervention: CC-90006
CC-90006; Dose Level 2
CC-90006 will be administered by subcutaneous injection in the abdomen
Intervention: CC-90006
CC-90006; Dose Level 3
CC-90006 will be administered by subcutaneous injection in the abdomen
Intervention: CC-90006
CC-90006; Dose Level 4
CC-90006 will be administered by subcutaneous injection in the abdomen
Intervention: CC-90006
CC-90006; Dose Level 5
CC-90006 will be administered by subcutaneous injection in the abdomen
Intervention: CC-90006
Placebo
Placebo will be administered by subcutaneous injection in the abdomen
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse Events (AEs)
Time Frame: Up to day 105
Number of participants with adverse events
Secondary Outcomes
- Pharmacokinetics- Cmax(Up to day 71)
- Pharmacokinetics- Tmax(Up to day 71)
- Pharmacokinetics- AUC0-∞(Up to day 71)
- Pharmacokinetics- AUC0-t(Up to day 71)
- Pharmacokinetics- T1/2(Up to day 71)
- Pharmacokinetics- CL/F(Up to day 71)
- Pharmacokinetics- Vz/F(Up to day 71)
- Pharmacokinetics- Anti-drug antibody(Up to day 71)