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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: Completed Phase 1 study, sponsored by Celltrion.
NCT04295356 is a Phase 1 study that has completed, run by Celltrion. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
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 |
What the finished NCT04295356 record still lists
NCT04295356 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (200% higher).
The record links to 0 conditions, and to 1 intervention - of which CT-P17 is the first listed.
NCT04295356 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04295356's enrollment target sits among peer trials
180 299th of 2000 higher than 1,690 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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