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drugset / Trial / NCT01585636

Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers

NCT01585636 ↗

Phase 1 Completed 62 enrolled Sequella, Inc. Quintiles, Inc. · collab
RandomizedSingle-groupQuadruple-blindTreatment

Summary

This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients with pulmonary tuberculosis.

Timeline

Start
2006-09
Primary completion
2007-02
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SQ109 Small molecule 5 mg Oral
Subject SQ109 Small molecule 10 mg Oral
Subject SQ109 Small molecule 20 mg Oral
Subject SQ109 Small molecule 50 mg Oral
Subject SQ109 Small molecule 100 mg Oral
Subject SQ109 Small molecule 200 mg Oral
Subject SQ109 Small molecule 300 mg Oral

Indications

tuberculosis