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NCT03981887 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
A Phase 1 study, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03981887: Completed Phase 1 study, sponsored by Wockhardt.
NCT03981887 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03981887, a Phase 1 study, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered: * Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. * Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.
Primary Outcome
By measuring treatment emergent AEs
Interventions
- OTHER Placebo
- DRUG Nafithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-06-18 |
| Est. Completion | 2019-08-07 |
| Phase | Phase 1 |
What the finished NCT03981887 record still lists
NCT03981887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03981887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03981887 about?
NCT03981887 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin". This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The followin...
What is the current status of trial NCT03981887?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-06-18. Estimated completion is 2019-08-07.
What interventions are being tested in trial NCT03981887?
The interventions under investigation include: Placebo (OTHER), Nafithromycin (DRUG).
Who is sponsoring clinical trial NCT03981887?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03981887's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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