Healthy
Conditions
Keywords
Bioequivalence
Brief summary
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.
Detailed description
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period. The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.
Interventions
DRUGCHS-1701
DRUGPegfilgrastim
Sponsors
Coherus Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 urine pregnancy test in women of childbearing potential
Exclusion criteria
1. Previous exposure to pegfilgrastim or filgrastim 2. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder 3. History of chronic or acute respiratory illness within the past 3 months 4. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation 5. No prescription or nonprescription drugs during the study 6. Participation in an investigational clinical study within 30 days prior to screening 7. History of known clinically significant drug and/or food allergies, including allergic reaction to latex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioequivalence as measured by PK and PD | 84 Days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Profile: Cmax | 84 Days | Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax) |
| PK Profile: tmax | 84 Days | Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax) |
| PK Profile: AUC0-t | 84 Days | Characterization of the PK profile of CHS-1701 using standard parameters of area under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC0-t) |
| PK Profile: t1/2 | 84 Days | Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (t1/2) |
| Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs) | 84 Days | Characterization of the safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs). |
Countries
United States
Outcome results
None listed