PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

Scientific Center for Anti-infectious Drugs (SCAID)

Status and phase: Completed; Phase 1

Conditions: Infections, Respiratory

Treatments: Other: Placebo PA; Drug: Potentiator of antibiotics (PA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04174937

PA-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Potentiator of antibiotics (PA)

Experimental group

Description:

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)

Treatment:

Drug: Potentiator of antibiotics (PA)

Patients taking placebo PA

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo PA