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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Sequence A

3 doses of CHS-1701 or Neulasta, random order

Group Type EXPERIMENTAL

CHS-1701

Intervention Type DRUG

Pegfilgrastim

Intervention Type DRUG

Sequence B

3 doses of CHS-1701 or Neulasta, random order

Group Type EXPERIMENTAL

CHS-1701

Intervention Type DRUG

Pegfilgrastim

Intervention Type DRUG

Sequence C

3 doses of CHS-1701 or Neulasta, random order

Group Type EXPERIMENTAL

CHS-1701

Intervention Type DRUG

Pegfilgrastim

Intervention Type DRUG

Interventions

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CHS-1701

Intervention Type DRUG

Pegfilgrastim

Intervention Type DRUG

Other Intervention Names

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Neulasta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes