Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta

Coherus BioSciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pegfilgrastim; Drug: CHS-1701

Study type: Interventional

Funder types: Industry

Identifiers

NCT02650973

CHS-1701-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

122 participants in 3 patient groups

Sequence A

Experimental group

Description:

3 doses of CHS-1701 or Neulasta, random order

Treatment:

Drug: CHS-1701

Drug: Pegfilgrastim

Sequence B

Experimental group

Description:

3 doses of CHS-1701 or Neulasta, random order

Treatment:

Drug: CHS-1701

Drug: Pegfilgrastim

Sequence C

Experimental group

Description:

3 doses of CHS-1701 or Neulasta, random order

Treatment:

Drug: CHS-1701

Drug: Pegfilgrastim