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NCT02061358 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT02061358: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT02061358 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02061358, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.
Primary Outcome
TEAEs are those AEs occurring only after administration of investigational product
Interventions
- DRUG UV-4B 3 mg
- DRUG UV-4B 10 mg
- DRUG UV-4B 30 mg
- DRUG UV-4B 90 mg
- DRUG UV-4B 180 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT02061358 record still lists
NCT02061358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which UV-4B 3 mg is the first listed.
NCT02061358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02061358 about?
NCT02061358 is a clinical study titled "Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects". The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.
What is the current status of trial NCT02061358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2014-07. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02061358?
The interventions under investigation include: UV-4B 3 mg (DRUG), UV-4B 10 mg (DRUG), UV-4B 30 mg (DRUG), UV-4B 90 mg (DRUG), UV-4B 180 mg (DRUG).
Who is sponsoring clinical trial NCT02061358?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02061358's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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