Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01465139 | A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers | PHASE1 | COMPLETED | 30 | — | — | Oct 1, 2011 | Jan 1, 2013 | Jun 27, 2017 | 1 | United States |
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX301.
| Arm | Type | Description |
|---|---|---|
| CDX-301 | EXPERIMENTAL | CDX-301 (rhuFlt3L), administered to healthy patients. |
| Name | Type | Description |
|---|---|---|
| CDX-301 | DRUG | CDX-301, administered in multiple dosages and frequencies depending on arm: n=3-6 at between 1-75 μg/kg over 5 days n=3-6 at 25 μg/kg over 7 days n=3-6 at 25 μg/kg over 10 days |
Inclusion Criteria: Among other criteria, volunteers must meet the following conditions to be eligible for the study: 1. Ages 18 - 55 2. Body Weight ≤ 120 kg 3. Generally good health and without significant medical conditions 4. Willing to use effective method of contraception 5. Abstinence from a...