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NCT02385851 · ClinicalTrials.gov registry record · Phase 1
Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)
A Phase 1 study, sponsored by Coherus Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT02385851 is a Phase 1 study that has completed, run by Coherus Oncology. The registered enrollment target is 116 participants.
The verdict
NCT02385851, a Phase 1 study, has completed, sponsored by Coherus Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
Interventions
- DRUG Pegfilgrastim
- DRUG CHS-1701
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02385851
The ClinicalTrials.gov registry entry for NCT02385851 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Coherus Oncology, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pegfilgrastim is the first listed.
NCT02385851 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02385851 about?
NCT02385851 is a clinical study titled "Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)". This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
What is the current status of trial NCT02385851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2015-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02385851?
The interventions under investigation include: Pegfilgrastim (DRUG), CHS-1701 (DRUG).
Who is sponsoring clinical trial NCT02385851?
This trial is sponsored by Coherus Oncology, which has 15 total clinical trials registered on ClinicalTrials.gov.
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