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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: Nafithromycin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03981887

W-4873-105

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Nafithromycin 200 mg as IV infusion

Experimental group

Description:

Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.

Treatment:

Drug: Nafithromycin

placebo administered as IV infusion

Placebo Comparator group

Description:

Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.

Treatment:

Other: Placebo