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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02385851 | Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim) | PHASE1 | COMPLETED | 116 | — | — | Feb 1, 2015 | Jul 1, 2015 | Aug 13, 2015 | 1 | United States |
The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).
| Arm | Type | Description |
|---|---|---|
| CHS-1701/Neulasta | EXPERIMENTAL | CHS-1701 followed by Neulasta (crossover) |
| Neulasta/CHS-1701 | EXPERIMENTAL | Neulasta followed by CHS-1701 (crossover) |
| Name | Type | Description |
|---|---|---|
| CHS-1701 | DRUG | - |
| Pegfilgrastim | DRUG | - |
Inclusion Criteria: 1. Adult male or female of ages 18 to 50 inclusive 2. Body weight \> 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive 3. Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination 4. Negative urin...