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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Nafithromycin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nafithromycin 200 mg as IV infusion<br>Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. | Drug: Nafithromycin<br>* Nafithromycin 200 mg as IV infusion<br>|
| Placebo Comparator: placebo administered as IV infusion<br>Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. | Other: Placebo<br>* placebo administered as IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety | By measuring treatment emergent AEs | Day 19 | 
| To assess multiple dose drug tolerability | By measuring treatment emergent AEs | Day 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess plasma PK parameters profile | Area under the plasma concentration-time curve (AUC) | Day 3 | 
| To assess plasma PK parameters profile | Maximum observed plasma concentration (Cmax) | Day 3 | 
| To assess plasma PK parameters profile | Time to Cmax (Tmax) | Day 3 | 
| To assess plasma PK parameters profile | Terminal half-life (t1/2) | Day 3 |