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NCT04295356 · ClinicalTrials.gov registry record · Phase 1
To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17
A Phase 1 study, sponsored by Celltrion.
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT04295356 is a Phase 1 study that has completed, run by Celltrion. The registered enrollment target is 180 participants.
The verdict
NCT04295356, a Phase 1 study, has completed, sponsored by Celltrion.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study Summary
This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm, all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks during which PK, safety, and immunogenicity measurements were made. The randomization to treatment assignment was stratified by body weight (≥80 kg vs. \<80 kg) as measured on baseline (Day -1), gender (male vs. female) and study center.
Interventions
- BIOLOGICAL CT-P17
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2019-06-21 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04295356
The ClinicalTrials.gov registry entry for NCT04295356 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celltrion, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CT-P17 is the first listed.
NCT04295356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04295356 about?
NCT04295356 is a clinical study titled "To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17". This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of th...
What is the current status of trial NCT04295356?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2019-06-21. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT04295356?
The interventions under investigation include: CT-P17 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04295356?
This trial is sponsored by Celltrion, which has 6 total clinical trials registered on ClinicalTrials.gov.
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