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PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

NCT04174937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-11-22

No results posted yet for this study

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.

Conditions

  • Infections, Respiratory

Interventions

DRUG

Potentiator of antibiotics (PA)

Intervention is administered to patients in this Arm

OTHER

Placebo PA

Intervention is administered to patients in this Arm

Sponsors & Collaborators

  • Institute Of Cardiology & Internal Diseases, Kazakhstan

    collaborator OTHER_GOV

  • Al-Farabi Kazakh National University (KazNU)

    collaborator UNKNOWN

  • Scientific Center for Anti-infectious Drugs, Kazakhstan

    lead INDUSTRY

Principal Investigators

  • Amirkan A Azembayev, PhD · JSC "Scientific Center for Anti-infectious Drugs"

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-17
Primary Completion
2019-05-15
Completion
2019-09-15

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04174937 on ClinicalTrials.gov