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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: CC-90006

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase 1 Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Number of participants with adverse events	Up to day 105

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics- Cmax	Observed maximum serum concentration	Up to day 71
Pharmacokinetics- Tmax	Time to Observed maximum serum concentration	Up to day 71
Pharmacokinetics- AUC0-∞	Area under the serum concentration-time curve calculated from time zero to infinity	Up to day 71
Pharmacokinetics- AUC0-t	Area under the serum concentration-time curve calculated from time zero to the last measured time point	Up to day 71
Pharmacokinetics- T1/2	Terminal half-life (T1/2)	Up to day 71
Pharmacokinetics- CL/F	Apparent clearance of drug from serum when dosed subcutaneously	Up to day 71
Pharmacokinetics- Vz/F	Apparent volume of distribution when dosed subcutaneously during the terminal phase	Up to day 71
Pharmacokinetics- Anti-drug antibody	A measure of the body's immune response to CC-90006	Up to day 71

Collaborators and Investigators

• Sponsor: Celgene

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2016
• Primary Completion (ACTUAL): August 15, 2017
• Study Completion (ACTUAL): August 15, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (ESTIMATE): October 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Healthy subjects; Phase 1; Tolerability; CC-90006
• Other Study ID Numbers: CC-90006-CP-001