PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

• Status: Completed
• Trial end date: 2019-09-15
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan
• Collaborators: Al-Farabi Kazakh National University (KazNU); Institute Of Cardiology & Internal Diseases, Kazakhstan
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

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