Immunity, Humoral
Conditions
Brief summary
This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.
Interventions
DRUGCHS-1701
Sponsors
Coherus Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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 urine pregnancy test in women of childbearing potential
Exclusion criteria
1. Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol) 2. Chemistry and hematology values outside protocol specified range 3. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder 4. History of chronic or acute respiratory illness within the past 4 weeks 5. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation 6. No prescription or nonprescription drugs during the study 7. Participation in an investigational clinical study within 30 days prior to screening 8. Known or suspected allergic reaction to latex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the immunogenicity of CHS-1701 compared to Neulasta | 84 days | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t) | 84 days |
| Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC) | 84 days |
| Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, and local injection site reactions (ISRs) | 84 days |
Countries
United States
Outcome results
None listed