A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02770404

Enrollment

Registered

2016-05-12

Start date

2016-04-25

Completion date

2016-12-25

Last updated

2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.

Interventions

DRUGNafithromycin

100, 200, or 400 mg of nafithromycin

DRUGPlacebo

IV matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female subject between 18 and 55 years of age, both inclusive, * creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).

Exclusion criteria

1. Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study. 2. Drug or food allergy.

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration-time curve	72 hours from dosing
Maximum observed plasma concentration (Cmax)	72 hours from dosing
Time to Cmax (Tmax)	72 hours from dosing

Secondary

Measure	Time frame
Number of subjects with any abonormal physical examination findings	14 days
clinical laboratory- Number of subjects with deranged heamatology parameters test results	14 days
Total number of reported AEs	14 days
12-lead safety ECG results	14 days
Number of subjects reported with any local tolerability at the injection site assessments	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026