Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CHS-1701 · 1 trial · 1 indication
The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response
| Arm | Type | Description |
|---|---|---|
| CHS-1701 | EXPERIMENTAL | CHS-1701 followed by CHS-1701 |
| Neulasta | ACTIVE_COMPARATOR | Neulasta followed by Neulasta |
| Name | Type | Description |
|---|---|---|
| CHS-1701 | DRUG | - |
| Pegfilgrastim (Neulasta) | 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...
CHS-1701 is an investigational small molecule developed by Coherus Oncology, Inc. (ticker CHRS). It was studied in the immunology therapeutic area for humoral immunity, with a focus on assessing immune response to subcutaneous dosing. It is a Phase 1 candidate and is not described as approved.
CHS-1701 targets CSF3R, the colony stimulating factor 3 receptor, which is a receptor-class molecular target. Its development program focused on humoral immunity and the immunogenicity of subcutaneous dosing rather than on a specific disease indication.
CHS-1701 is developed by Coherus Oncology, Inc., which trades under the ticker CHRS. The company sponsored the clinical work evaluating the asset, including a Phase 1 study comparing subcutaneous doses of CHS-1701 with subcutaneous doses of Neulasta.
CHS-1701 is in Phase 1 development. Its single recorded trial, NCT02418104, is a completed Phase 1 study, and no active trials are listed. The program is investigational, and the available information does not describe it as approved.
CHS-1701 has been studied in one clinical trial, NCT02418104, titled Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta. It was a completed Phase 1 trial conducted in the United States with 303 enrolled participants.
The Phase 1 trial NCT02418104 was a randomized, double-blind, active-controlled study with 303 participants, comparing two subcutaneous doses of CHS-1701 with two subcutaneous doses of Neulasta. It enrolled healthy volunteers aged 18 years and older in the United States and has been completed.