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Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin

NCT03981887 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-10-02

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Nafithromycin

Nafithromycin 200 mg as IV infusion

OTHER

Placebo

placebo administered as IV infusion

Sponsors & Collaborators

  • Clinartis, LLC

    collaborator UNKNOWN

  • Keystone Bioanalytical, Inc.

    collaborator UNKNOWN

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Carlos Sanabria, MD · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2019-07-02
Completion
2019-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981887 on ClinicalTrials.gov