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NCT02650973 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Coherus Oncology.

Completed
Registry status
Phase 1
Development phase
122
Enrollment target
4
Study locations

NCT02650973 is a Phase 1 study of Healthy that has completed, run by Coherus Oncology. The registered enrollment target is 122 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT02650973, a Phase 1 study of Healthy, has completed, sponsored by Coherus Oncology.

COMPLETED
Registry status
Phase 1
Development phase
122 participants
Enrollment target
4
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Pegfilgrastim
  • DRUG CHS-1701

Study Locations (4)

California

  • WCCT - Cypress

Ohio

  • Medpace CPU - Cincinnati

Texas

  • ICON - San Antonio

Wisconsin

  • Spaulding - West Bend

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2016-02
Est. Completion 2016-06
Phase Phase 1

Sponsor

Coherus Oncology

15 total trials

What the Registry Record Tells You About NCT02650973

The ClinicalTrials.gov registry entry for NCT02650973 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower). The listed sponsor is Coherus Oncology, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Pegfilgrastim is the first listed.

NCT02650973 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Ohio, Texas.

Frequently Asked Questions

What is clinical trial NCT02650973 about?

NCT02650973 is a clinical study titled "Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta". 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.

What is the current status of trial NCT02650973?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2016-02. Estimated completion is 2016-06.

What conditions does trial NCT02650973 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT02650973?

The interventions under investigation include: Pegfilgrastim (DRUG), CHS-1701 (DRUG).

Who is sponsoring clinical trial NCT02650973?

This trial is sponsored by Coherus Oncology, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02650973 being conducted?

This trial has 4 study locations across California, Ohio, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.