Dose Escalation Study of SQ109 in Healthy Adult Volunteers
Condition: TB Multi-drug Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine: how safe it is to take SQ109 (an experimental
      tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how
      well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time;
      the amounts that can be detected in the blood; and how long it stays in the body. The study
      involves 30 volunteers: 24 will receive SQ109 and 6 will receive placebo (inactive
      substance). Qualified participants will be admitted to the study unit within 28 days from the
      screening and stay as inpatient for approximately 2 weeks. During this period they will
      receive study drug and complete all scheduled procedures including multiple blood draws.
      After discharge, there is a 14 day follow up period. Total study participation is about 56
      days.
    

Detailed description: 
      Tuberculosis (TB) is one of the most important global health problems. According to recent
      estimates from the World Health Organization, 8 million new cases of TB and 1.9 million
      deaths from TB occur annually, making TB the second leading cause of death from an infectious
      pathogen. Due to multidrug resistant TB, the need for new and more effective drugs to treat
      TB is well recognized. This study is a phase 1B, prospective, single-center, double-blinded,
      randomized, placebo-controlled, clinical study of SQ109 to evaluate single-daily dose
      tolerability and pharmacokinetics (PK) of oral SQ109 in healthy subjects. The objectives of
      the study are to: determine the safety and tolerability of SQ109 administered daily for 14
      days in healthy male and female volunteers; assess single dose and multiple dose PK of SQ109
      administered daily for 14 days in healthy male and female volunteers; and assess single dose
      and multiple dose PK of SQ109 administered twice per week after a 5-day loading regimen in
      healthy, male and female volunteers. A total of 30 subjects, ages 18-45, will be enrolled in
      the study, allocated equally among 3 cohorts of 10 subjects each, 8 treated with active drug
      and 2 with placebo. Subjects in Cohorts 1 and 3 will receive an oral dose of 75 mg or 150 mg,
      respectively, of study medication daily for 14 days. Subjects in Cohort 2 will receive 150 mg
      daily for 5 days followed by 2 additional doses of 150 mg on Days 9 and 14. Subject
      participation will include a screening visit within 28 days of study entry, a 14 day
      in-patient treatment period, and a 14 day out-patient follow-up phase. Safety will be
      assessed by study personnel continually during the 14 day in-patient treatment period and the
      out-patient follow-up phase. Adverse events will be recorded for all subjects. Other safety
      measures include laboratory tests, electrocardiograms (ECGs), visual and neurological
      assessments, physical examinations, and vital signs. Study duration will be approximately 6
      months. Subject participation duration will be 56 days.
    

Intervention name(s): SQ109; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SQ109 150 mg is an oval, coated, white, scored tablet. Dosages: 75 mg administered once daily for 14 days; 150 mg administered once daily on Days 1-5, 9, and 14; and 150 mg administered once daily for 14 days.; Placebo is an oval, coated, white, scored tablet administered once daily for 14 days or on Days 1-5, 9, and 14.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mycobacterium tuberculosis, SQ109