Trials / Completed
CompletedNCT02934269
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | |
| DRUG | CC-90006 |
Timeline
- Start date
- 2016-11-21
- Primary completion
- 2017-08-15
- Completion
- 2017-08-15
- First posted
- 2016-10-14
- Last updated
- 2018-02-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02934269. Inclusion in this directory is not an endorsement.