A Phase 1 TP-271 Oral PK Multiple Ascending Dose Study
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple
      ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy
      adult subjects. Male or female subjects aged 18 to 50 years who fulfill the
      inclusion/exclusion criteria will be enrolled in this study.
    

Detailed description: 
      This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple
      ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy
      adult subjects. Male or female subjects aged 18 to 50 years who fulfill the
      inclusion/exclusion criteria will be enrolled in this study.

      Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. Subjects
      in each cohort will be randomized 6:2 to receive multiple oral doses of TP 271 or placebo.
      Every effort will be made to dose all subjects in a cohort on the same day.

      Doses of study drug will be administered orally either once daily in the morning or twice
      daily in the morning and evening from Days 1 to 7. In all subjects, the morning dose will be
      administered following an overnight fast (minimum 8 hours) of food and all beverages, except
      for water. For subjects in Cohorts D and E only, the evening dose will be administered
      following a minimum 3-hour fast of food and all beverages, except for water. Fasting in all
      cohorts will continue for at least 2 hours following each study drug administration.

      During the Screening Period (within 28 days prior to the subject receiving study drug), each
      subject will be assessed for eligibility. Each subject must sign and date an ICF prior to
      undergoing any study-related procedures.
    

Intervention name(s): TP-271
Intervention type(s): Drug
Intervention description(s): multiple oral doses of TP-271 or placebo, randomized 6:2, doses escalating 50 mg, 100 mg, 200 mg, 300 mg, 400 mg once daily for 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Up to 5 cohorts of 8 subjects each will be enrolled. Subjects in each cohort will be randomized 6:2 to receive multiple oral doses of TP 271 at 1 of 5 ascending doses of TP-271 or placebo once or twice daily for 7 days, as shown in the table below. Every effort will be made to dose all subjects in a cohort on the same day.
Proposed Oral Doses of Study Drug by Dose Cohort Cohort Dose Regimen Proposed Oral Dose A Once daily 50 mg TP-271 q24 (n = 6) or matching placebo (n = 2) B Once daily 100 mg TP-271 q24 (n = 6) or matching placebo (n = 2) C Once daily 200 mg TP-271 q24 (n = 6) or matching placebo (n = 2) D Once daily 300 mg TP-271 q24 (n = 6) or matching placebo (n = 2) E Once daily 400 mg TP-271 q24 (n = 6) or matching placebo (n = 2) Abbreviations: q24 = every 24 hours.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other