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

NCT02934269 | Completed Phase 1

• 1 other identifier: CC-90006-CP-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy subjects; Safety; CC-90006; Phase 1; Tolerability

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse events

  Up to day 105

Secondary Outcomes (8)

• 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

Study Arms (6)

CC-90006; Dose Level 1

EXPERIMENTAL

CC-90006 will be administered by subcutaneous injection in the abdomen

Drug: CC-90006

CC-90006; Dose Level 2

EXPERIMENTAL

CC-90006 will be administered by subcutaneous injection in the abdomen

Drug: CC-90006

CC-90006; Dose Level 3

EXPERIMENTAL

CC-90006 will be administered by subcutaneous injection in the abdomen

Drug: CC-90006

CC-90006; Dose Level 4

EXPERIMENTAL

CC-90006 will be administered by subcutaneous injection in the abdomen

Drug: CC-90006

CC-90006; Dose Level 5

EXPERIMENTAL

CC-90006 will be administered by subcutaneous injection in the abdomen

Drug: CC-90006

Placebo

EXPERIMENTAL

Placebo will be administered by subcutaneous injection in the abdomen

Drug: Placebo

Interventions

Placebo DRUG

Placebo

CC-90006 DRUG

CC-90006; Dose Level 1; CC-90006; Dose Level 2; CC-90006; Dose Level 3; CC-90006; Dose Level 4; CC-90006; Dose Level 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

PPD Phase 1 Unit

Austin, Texas, 78744, United States

Location

Study Officials

• Leon Carayannopoulos, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: November 21, 2016
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (1)