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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: Completed Phase 1 study, sponsored by Coherus Oncology.
NCT02385851 is a Phase 1 study that has completed, run by Coherus Oncology. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
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®.
Primary Outcome
The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).
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 |
What the finished NCT02385851 record still lists
NCT02385851 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 2 interventions - of which Pegfilgrastim is the first listed.
NCT02385851 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02385851's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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