PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

NCT04174937 | Completed Phase 1 DMC

• 1 other identifier: PA-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Safety; Iodine complex; Pharmacokinetics; Antibiotic potentiator

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  The safety of ascending single and multiple doses of Study Drug in healthy male subjects will be assessed by adverse event and serious adverse event monitoring.

  Adverse event reporting will be performed throughout the trial from the Screening visit until the Final visit (up to 90 days)

Secondary Outcomes (75)

• Area under plasma concentration time curve (AUC∞)

  Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

• Maximum concentration of drug in the blood (Cmax)

  Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

• Time to reach maximum drug concentration (Tmax)

  Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

• Half-life time (T1/2)

  Blood collections at the following time points: 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

• Total clearance (СL)

  Blood collections at the following time points: before drug intake (two points - 1 day and 10 min), and 5 min, 15 min, 30 min, and 1, 1.5; 2; 3; 6; 9; 12; 15; 24; 48 and 72 hours after study drug administration

Study Arms (2)

Potentiator of antibiotics (PA)

EXPERIMENTAL

Potenciator of antibiotics (PA) , albumin complex of tetraiodid was given per os, single and multiple doses for the different periods (but not exceeding 14 days)

Drug: Potentiator of antibiotics (PA)

Patients taking placebo PA

PLACEBO COMPARATOR

Placebo without any active pharmaceutical ingredients was given per os dosed for the patients in same periods of time as per experimental group, single and multiple doses for the different periods (but not exceeding 14 days)

Other: Placebo PA

Interventions

Potentiator of antibiotics (PA) DRUG

Intervention is administered to patients in this Arm

Also known as: Albumin complex of tetraiodide

Potentiator of antibiotics (PA)

Placebo PA OTHER

Intervention is administered to patients in this Arm

Patients taking placebo PA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 55 years
• Body mass index 16 to 30
• Subjects should be in good physical and mental health based on medical history, clinical examination and laboratory investigations
• Subjects should have signed informed consent prior to screening and the clinical study after they have read and understood the objective, conduct, risks related to the study, and their rights as study participants
• Subjects should have signed informed consent for being tested for HIV
• Subjects should have signed informed consent to be tested for alcoholemia, use of cannabinoids, cocaine, morphine, benzodiazepines, barbiturates and amphetamine

You may not qualify if:

• Subjects should not have evidence of any physical and/or mental health issues at screening and/or results of any clinical, laboratory and/or technical procedures at screening outside of the normal range
• Subjects should not be taking any concomitant medication
• Subjects should not have a history of allergies, hypersensitivity or intolerance to iodine or iodide or to medicines containing iodine such as contrast media used for radiologic examinations
• Subjects should not have a history of addiction or abuse of drugs or alcohol
• Subjects should not be in a position of subordination or other dependence on persons involved in the study such as sponsor, investigators, or any other person or institution interested in its results
• Subjects should not be members of the armed forces or prison inmates
• Subjects should not have positive serology for Hepatitis B, Hepatitis C or HIV
• Subjects should not have any apparent functional and/or physical defects which may or interfere with the study or distort results

Sponsors & Collaborators

• Scientific Center for Anti-infectious Drugs, Kazakhstan: lead
• Institute Of Cardiology & Internal Diseases, Kazakhstan: collaborator
• Al-Farabi Kazakh National University (KazNU): collaborator

Study Sites (1)

Institute Of Cardiology & Internal Diseases

Almaty, Almatinskaya, A05B0H6, Kazakhstan

Location

Related Links

• Information about the organization developed and produced new drug
• Structure and possible mechanism of action of new drug
• Interaction of iodine complexes with viral DNA
• Quantitative Determination of Iodide Ions in Substances and Tablets Containing Iodine Adducts

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Amirkan A Azembayev, PhD

  JSC "Scientific Center for Anti-infectious Drugs"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: November 22, 2019
• Study Start: June 17, 2016
• Primary Completion: May 15, 2019
• Study Completion: September 15, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)