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CHS-1701 · 3 trials · 3 indications
The primary objective of this study is to assess the bioequivalence of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)
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
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 |
|---|---|---|
| Sequence A | EXPERIMENTAL | 3 doses of CHS-1701 or Neulasta, random order |
| Sequence B | EXPERIMENTAL | 3 doses of CHS-1701 or Neulasta, random order |
| Sequence C | EXPERIMENTAL | 3 doses of CHS-1701 or Neulasta, random order |
| CHS-1701 | EXPERIMENTAL | CHS-1701 followed by CHS-1701 |
| Neulasta | ACTIVE_COMPARATOR | Neulasta followed by Neulasta |
| 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 | - |
| Pegfilgrastim (Neulasta) | DRUG | - |
Inclusion Criteria: 1. Adult male or female of ages 18 to 45 inclusive 2. Body weight \> 50 kg (110 lb.) and body mass index between 18 and 28 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 being studied for bioequivalence, humoral immunity, and healthy volunteer indications. It is being developed as a potential biosimilar to Neulasta (pegfilgrastim). Clinical trials have assessed its pharmacokinetic and pharmacodynamic biosimilarity, as well as its immunogenicity, in healthy adult participants.
CHS-1701 is being developed by Coherus Oncology, Inc., a subsidiary of Coherus BioSciences (NASDAQ: CHRS). The company has conducted Phase 1 clinical trials in the United States to evaluate the drug's biosimilarity to Neulasta.
CHS-1701 is in Phase 1 clinical development. All three completed trials were Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development as a potential biosimilar to pegfilgrastim.
CHS-1701 has completed three Phase 1 trials: NCT02385851 compared pharmacokinetic and pharmacodynamic biosimilarity with Neulasta in 116 participants; NCT02418104 assessed immunogenicity in 303 participants; and NCT02650973 evaluated bioequivalence in 122 participants. All were randomized, double-blind, controlled studies in healthy volunteers in the United States.
CHS-1701 is being developed as a biosimilar to Neulasta, which is pegfilgrastim. The clinical trials directly compared CHS-1701 with Neulasta to assess biosimilarity in pharmacokinetics, pharmacodynamics, and immunogenicity. However, CHS-1701 is an investigational product and has not been established as interchangeable with the reference product.