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

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Wockhardt

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo
Drug: Nafithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02770404
W-4873-102 SAD study

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Nafithromycin
Experimental group
Description:
Subjects in Cohorts 1 through 5 receive active treatments. Subjects in Cohort 6 will 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 on Day 1
Treatment:
Drug: Nafithromycin
Placebo
Placebo Comparator group
Description:
Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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