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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-90006; Dose Level 1 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen |
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| CC-90006; Dose Level 2 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen |
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| CC-90006; Dose Level 3 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen |
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| CC-90006; Dose Level 4 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen |
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| CC-90006; Dose Level 5 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen |
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| Placebo | Experimental | Placebo will be administered by subcutaneous injection in the abdomen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| CC-90006 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse events | Up to day 105 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Cmax | Observed maximum serum concentration | Up to day 71 |
| Pharmacokinetics- Tmax | Time to Observed maximum serum concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Carayannopoulos, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase 1 Unit | Austin | Texas | 78744 | United States |
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| 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 |