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A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02934269
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE October 13, 2016
First Posted Date  ICMJE October 14, 2016
Last Update Posted Date February 8, 2018
Actual Study Start Date  ICMJE November 21, 2016
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
Adverse Events (AEs) [ Time Frame: Up to day 105 ]
Number of participants with adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02934269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • Pharmacokinetics- Cmax [ Time Frame: Up to day 71 ]
    Observed maximum serum concentration
  • Pharmacokinetics- Tmax [ Time Frame: Up to day 71 ]
    Time to Observed maximum serum concentration
  • Pharmacokinetics- AUC0-∞ [ Time Frame: Up to day 71 ]
    Area under the serum concentration-time curve calculated from time zero to infinity
  • Pharmacokinetics- AUC0-t [ Time Frame: Up to day 71 ]
    Area under the serum concentration-time curve calculated from time zero to the last measured time point
  • Pharmacokinetics- T1/2 [ Time Frame: Up to day 71 ]
    Terminal half‐life (T1/2)
  • Pharmacokinetics- CL/F [ Time Frame: Up to day 71 ]
    Apparent clearance of drug from serum when dosed subcutaneously
  • Pharmacokinetics- Vz/F [ Time Frame: Up to day 71 ]
    Apparent volume of distribution when dosed subcutaneously during the terminal phase
  • Pharmacokinetics- Anti-drug antibody [ Time Frame: Up to day 71 ]
    A measure of the body's immune response to CC-90006
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Placebo
  • Drug: CC-90006
Study Arms  ICMJE
  • Experimental: CC-90006; Dose Level 1
    CC-90006 will be administered by subcutaneous injection in the abdomen
    Intervention: Drug: CC-90006
  • Experimental: CC-90006; Dose Level 2
    CC-90006 will be administered by subcutaneous injection in the abdomen
    Intervention: Drug: CC-90006
  • Experimental: CC-90006; Dose Level 3
    CC-90006 will be administered by subcutaneous injection in the abdomen
    Intervention: Drug: CC-90006
  • Experimental: CC-90006; Dose Level 4
    CC-90006 will be administered by subcutaneous injection in the abdomen
    Intervention: Drug: CC-90006
  • Experimental: CC-90006; Dose Level 5
    CC-90006 will be administered by subcutaneous injection in the abdomen
    Intervention: Drug: CC-90006
  • Experimental: Placebo
    Placebo will be administered by subcutaneous injection in the abdomen
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 15, 2017
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02934269
Other Study ID Numbers  ICMJE CC-90006-CP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leon Carayannopoulos, MD Celgene Corporation
PRS Account Celgene
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP