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

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: CC-90006 Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 21, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Arm Intervention/treatment
Experimental: CC-90006; Dose Level 1
CC-90006 will be administered by subcutaneous injection in the abdomen
Drug: CC-90006
Experimental: CC-90006; Dose Level 2
CC-90006 will be administered by subcutaneous injection in the abdomen
Drug: CC-90006
Experimental: CC-90006; Dose Level 3
CC-90006 will be administered by subcutaneous injection in the abdomen
Drug: CC-90006
Experimental: CC-90006; Dose Level 4
CC-90006 will be administered by subcutaneous injection in the abdomen
Drug: CC-90006
Experimental: CC-90006; Dose Level 5
CC-90006 will be administered by subcutaneous injection in the abdomen
Drug: CC-90006
Experimental: Placebo
Placebo will be administered by subcutaneous injection in the abdomen
Drug: Placebo



Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to day 105 ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics- Cmax [ Time Frame: Up to day 71 ]
    Observed maximum serum concentration

  2. Pharmacokinetics- Tmax [ Time Frame: Up to day 71 ]
    Time to Observed maximum serum concentration

  3. Pharmacokinetics- AUC0-∞ [ Time Frame: Up to day 71 ]
    Area under the serum concentration-time curve calculated from time zero to infinity

  4. 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

  5. Pharmacokinetics- T1/2 [ Time Frame: Up to day 71 ]
    Terminal half‐life (T1/2)

  6. Pharmacokinetics- CL/F [ Time Frame: Up to day 71 ]
    Apparent clearance of drug from serum when dosed subcutaneously

  7. Pharmacokinetics- Vz/F [ Time Frame: Up to day 71 ]
    Apparent volume of distribution when dosed subcutaneously during the terminal phase

  8. Pharmacokinetics- Anti-drug antibody [ Time Frame: Up to day 71 ]
    A measure of the body's immune response to CC-90006



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934269


Locations
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United States, Texas
PPD Phase 1 Unit
Austin, Texas, United States, 78744
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Leon Carayannopoulos, MD Celgene Corporation

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02934269     History of Changes
Other Study ID Numbers: CC-90006-CP-001
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Keywords provided by Celgene:
Healthy subjects
Safety
CC-90006
Phase 1
Tolerability