NCT03590600

A Single Ascending Dose Study of BTZ043

A Randomized, Double Blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Doses of BTZ043 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Michael Hoelscher · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics of single doses of BTZ043 in healthy adult volunteers. The study is conducted at a study centre in Germany. Up to 50 male and female participants will be included in this study in up to 5 cohorts; each cohort will consist of 10 subjects: in each cohort 8 subjects will be assigned to BTZ-043 and 2 to placebo. The doses tested will be: 125mg, 250mg, 500mg, 1000mg and 2000mg. Safety will be assessed via regular vital sign measurement, 12-lead ECG parameters, physical examination and safety laboratory assessments. Subjects will be hospitalized from Day -1 until discharge in the morning of Day 3. After completion of all Day 3 assessments of a cohort, blinded safety data will be reviewed and the next dose increment will be decided by the Trial Steering Committee (TSC).

Conditions

• Tuberculosis
• Tuberculosis, Pulmonary
• Bacterial Infections
• Lung Diseases
• Mycobacterium Infections

Interventions

Type	Name	Description
DRUG	BTZ-043	Powder and solvent for oral suspension
DRUG	Placebo	Matching placebo: powder and solvent for oral suspension

Timeline

• Start date: 2018-06-07
• Primary completion: 2018-08-14
• Completion: 2019-03-05
• First posted: 2018-07-18
• Last updated: 2019-03-07

Locations

1 site across 1 country: Germany