Clinical trial NCT02934269: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy subjects
Safety
CC-90006
Phase 1
Tolerability
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to day 105
Secondary outcomes:
measure: Pharmacokinetics- Cmax
timeFrame: Up to day 71
measure: Pharmacokinetics- Tmax
timeFrame: Up to day 71
measure: Pharmacokinetics- AUC0-∞
timeFrame: Up to day 71
measure: Pharmacokinetics- AUC0-t
timeFrame: Up to day 71
measure: Pharmacokinetics- T1/2
timeFrame: Up to day 71
measure: Pharmacokinetics- CL/F
timeFrame: Up to day 71
measure: Pharmacokinetics- Vz/F
timeFrame: Up to day 71
measure: Pharmacokinetics- Anti-drug antibody
timeFrame: Up to day 71
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase 1 Unit
state: Texas
Study officials:
affiliation: Celgene Corporation
name: Leon Carayannopoulos, MD
role: STUDY_DIRECTOR
References: