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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 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 10 participants.

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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.

Interventions

  • OTHER Placebo
  • DRUG Nafithromycin

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-06-18
Est. Completion 2019-08-07
Phase Phase 1

Sponsor

Wockhardt

27 total trials

What the Registry Record Tells You About NCT03981887

The ClinicalTrials.gov registry entry for NCT03981887 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03981887 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.