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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: Completed Phase 1 study of Healthy, sponsored by Coherus Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of this study is to assess the bioequivalence of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)
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
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02650973 record still lists
NCT02650973 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02650973's enrollment target sits among peer trials
122 179th of 1090 higher than 911 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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