NCT04174937

PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

A Randomized, Placebo-controlled Study of the Tolerability, Safety and Pharmacokinetics of PA in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human (FIH) study to explore the safety, tolerability and pharmacokinetics of PA after oral ascending dose administration to healthy male volunteers.

Detailed description

The first-in-human dose (FHD) trial is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of PA in healthy male subjects. The study consists of two stages: single dose administration and multiple dose administration. The single dose administration stage includes 5 cohorts, multiple dose administration stage includes at least 4 cohorts (groups). Each cohort includes 8 subjects (6 active drugs and 2 placebos). Cohorts intake ascending doses of study drug. The dose of 1st cohort is 1,0 mg/ml, the doses for the following cohorts will be estimated by the Data Monitoring Committee based on pharmacokinetics and safety results of previous group. For each subject study includes screening period, one baseline period on Day -1, a treatment period (1 day - at single dose stage; 14 days - at multiple dose stage), followed by safety, PK, assessments up to 72-96 hours post dose. Follow-up visits will take place on Day 7 ; 30; 60 (single dose stage) and 30; 60; 90 (multiple dose stage).

Conditions

• Infections, Respiratory

Interventions

Type	Name	Description
DRUG	Potentiator of antibiotics (PA)	Intervention is administered to patients in this Arm
OTHER	Placebo PA	Intervention is administered to patients in this Arm

Timeline

• Start date: 2016-06-17
• Primary completion: 2019-05-15
• Completion: 2019-09-15
• First posted: 2019-11-22
• Last updated: 2019-11-22

Locations

1 site across 1 country: Kazakhstan