NCT04428593

Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers

Double Blind, Randomized, Placebo-controlled Study of Safety and Tolerability of Treamid in Rising Doses at Single and Then Multiple Oral Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: PHARMENTERPRISES LLC · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Treamid 5 mg	The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
DRUG	Treamid 15 mg	The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
DRUG	Treamid 50 mg	The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
DRUG	Placebo	The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.

Timeline

• Start date: 2016-01-25
• Primary completion: 2016-11-21
• Completion: 2016-11-21
• First posted: 2020-06-11
• Last updated: 2020-06-17