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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03981887

Enrollment

Registered

2019-06-11

Start date

2019-06-18

Completion date

2019-08-07

Last updated

2019-10-02

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

Conditions

Healthy

Brief 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

DRUGNafithromycin

Nafithromycin 200 mg as IV infusion

OTHERPlacebo

placebo administered as IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Body mass index (BMI) ≥18 to ≤32 kg/m2, both inclusive. * Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results * Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1). * Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening. * Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the investigator

Exclusion criteria

* Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before study drug administration in this study. * History/evidence of clinically relevant pathology * History of clinically significant food or drug allergy * Positive alcohol or urine drug screen

Design outcomes

Primary

Measure	Time frame	Description
To assess safety	Day 19	By measuring treatment emergent AEs
To assess multiple dose drug tolerability	Day 19	By measuring treatment emergent AEs

Secondary

Measure	Time frame	Description
To assess plasma PK parameters profile	Day 3	Area under the plasma concentration-time curve (AUC)

Countries

United States

Outcome results

None listed

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