Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and
      tolerability of increasing doses of Treamid after single and repeated oral administration in
      healthy volunteers. The volunteers received the study drug once, and then continued daily
      intake for 14 days after a 6-day break. The primary objective of the study was to evaluate
      the safety and tolerability profile of Treamid after single and multiple administration based
      on the frequency and severity of adverse events and changes in vital signs, laboratory
      results, electrocardiography and results of the physical examination. The secondary objective
      of the study was to assess pharmacokinetics of active pharmaceutical substance of Treamid.
    

Detailed description: 
      1 Russian center was approved for participation in this study and was initiated. Healthy
      volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single
      administration, multiple administration and follow-up.

      All eligible subjects were randomized into the study in appropriate cohort groups
      sequentially. Cohort 1 - Treamid or Placebo 5 mg once and then daily 14 days after a 6-day
      break; Cohort 2 - Treamid or Placebo 15 mg once and then daily during 14 days after a 6-day
      break; Cohort 3 - Treamid or Placebo 50 mg once and then daily during 14 days after a 6-day
      break. The decision regarding increasing of the study drug dose for a subsequent cohort was
      made by the Data Safety Monitoring Committee on the basis of preliminary safety results
      assessment. A total of 16 volunteers received Treamid (4 - 5 mg, 4 -15 mg, 8 - 50 mg) and a
      total of 4 volunteers received the placebo during the study participation. The follow-up
      period lasted for 4 weeks.
    

Intervention name(s): Treamid 5 mg; Treamid 15 mg; Treamid 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.; The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.; The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.; The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
Other intervention name(s): XC268BG; XC268BG; XC268BG
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The dose cohorts were included into the study subsequently based on preliminary safety results evaluation performed by the Data Safety Monitoring Committee. 3 doses of Treamid/placebo (5 mg, 15 mg and 50 mg) were used in the study.The duration of exposure to the study drug was 6 days in each cohort: Day 1, once, at the step of single administration, and then in 6 days, daily, 1 time a day for 14 days at the step of multiple administration.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; PHARMENTERPRISES; Phase I