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NCT03273842 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 422
- Enrollment target
- 4
- Study locations
NCT03273842: Completed Phase 1 study of Healthy Volunteers, sponsored by Pfizer.
NCT03273842 is a Phase 1 study of Healthy Volunteers that has completed, run by Pfizer. The registered enrollment target is 422 participants, below the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (12% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03273842, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 422 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams \[mg\]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.
Conditions Studied
Interventions
- BIOLOGICAL PF-06881894
- BIOLOGICAL US-approved Neulasta
Study Locations (4)
Florida
- Seaview A Quotient Clinical Business - Coral Gables
- Quotient Sciences- Jacksonville, LLC - Jacksonville
- Seaview A Quotient Clinical Business - Miami
Kansas
- Vince & Associates Clinical Research Inc. - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2018-07-25 |
| Phase | Phase 1 |
What the finished NCT03273842 record still lists
NCT03273842 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which PF-06881894 is the first listed.
NCT03273842 reports a single indexed study location in Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT03273842 about?
NCT03273842 is a clinical study titled "A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers". This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams \[mg\]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second...
What is the current status of trial NCT03273842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 422 participants. The study started on 2017-10-27. Estimated completion is 2018-07-25.
What conditions does trial NCT03273842 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03273842?
The interventions under investigation include: PF-06881894 (BIOLOGICAL), US-approved Neulasta (BIOLOGICAL).
Who is sponsoring clinical trial NCT03273842?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03273842 being conducted?
This trial has 4 study locations across Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03273842's enrollment target sits among peer trials
422 32nd of 283 higher than 252 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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