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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT02934269

Collaborator

(none)

Enrollment

Location

Arms

8.8

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Nov 21, 2016

Actual Primary Completion Date :

Aug 15, 2017

Actual Study Completion Date :

Aug 15, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Adverse Events (AEs) [Up to day 105]
Number of participants with adverse events

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Phase 1 Unit	Austin	Texas	United States	78744

Sponsors and Collaborators

Celgene

Investigators

Study Director: Leon Carayannopoulos, MD, Celgene Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celgene

ClinicalTrials.gov Identifier:

NCT02934269

Other Study ID Numbers:

CC-90006-CP-001

First Posted:

Oct 14, 2016

Last Update Posted:

Feb 8, 2018

Last Verified:

Feb 1, 2018

Keywords provided by Celgene

Study Results

No Results Posted as of Feb 8, 2018