An Open-label, Prospective Study of Safety, Tolerability, Pharmacokinetics and Food Effects of PBTZ169, 80 mg Capsules, When Used in Ascending Doses in Healthy Volunteers

Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers

开始日期2018-07-03

申办/合作机构

Nearmedic Plus Ltd.

NCT04626622 / CompletedN/A

Kagocel for Oral Administration for the Prevention of Influenza and Other Acute Respiratory Viral Diseases in Young People

This study evaluates the use of Kagocel for the prevention of acute respiratory viral infections (ARVI) and influenza during the epidemic rise in the incidence of diseases in Russia in 2018 (epidemiology: the number of cases during the period of Kagocel administration and follow-up, bacterial exacerbations, the number of repeated episodes (reinfection), demographics of patients, safety, adherence to treatment) in students at risk due to stress, lack of sleep and fatigue.

开始日期2018-02-15

申办/合作机构

Nearmedic Plus Ltd.

NCT04664127 / CompletedN/A

Clinical and Immunological Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection) by Acyclic Nucleoside Valacyclovir and Interferon Inducer Kagocel

This study examined the efficacy, safety and benefits of modern treatment and changes in the dynamics of the life of adult patients quality with severe herpes simplex in the current medical practice when combined therapy by acyclic nucleoside Valacyclovir and antiviral agent Kagocel versus monotherapy by Valacyclovir. This study also evaluated the structure of herpesvirus infections and the rate of mixed variants of the course, the rate of exacerbations of herpes simplex, the time of disappearance of human herpesvirus isolation and the features of the immune phenotype of patients taking different types of therapy.

开始日期2017-10-30

申办/合作机构

Nearmedic Plus Ltd.

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Terapevticheskii arkhiv4区 · 医学

The main results of clinical trials of the efficacy, safety and pharmacokinetics of the perspective anti-tuberculosis drug makozinone (PBTZ169)

4区 · 医学

ArticleOA

作者: Smerdin, S V ; Nikitina, N A ; Bolgarina, A A ; Shcherbakova, V S ; Mariandyshev, A O ; Khokhlov, A L ; Ozerova, I V ; Igumnova, O V

Tuberculosis is a chronic infectious disease, usually localized in the respiratory system and representing one of the most important global social and biomedical health problems associated with the spread of therapy-resistant forms (multidrug-resistant and extensively drug-resistant tuberculosis). One of the most promising targets for the development of antimycobacterial drugs is the enzyme DprE1, which is involved in the synthesis of the cell wall of mycobacteria. In the series of DprE1 inhibitor drugs, the most advanced drug is PBTZ169 (INN maсozinone). Clinical trials (CT) of the efficacy and safety of macozinone are conducted by the pharmaceutical company LLC NEARMEDIC PLUS in the Russian Federation, and in other countries (Sponsors: Innovative Medicines for Tuberculosis Foundation, cole polytechnique fdrale de Lausanne and Bill and Melinda Gates Foundation). The publication describes results of completed I, IIa and Ib phases CT, conducted in the Russian Federation. Aim. The goal of phase I CT was to assess the safety, tolerability and pharmacokinetics (PK) of PBTZ169, 40 mg capsule, after single and multiple administration under fasting conditions in increasing doses in healthy volunteers. The goal of phase IIa CT was to study the efficacy (in terms of early bactericidal activity EBA), safety and PK of the drug PBTZ169, 80 mg capsules, in various doses, when used as monotherapy in patients with newly diagnosed respiratory tuberculosis with bacterial excretion and retained sensitivity to isoniazid and rifampicin. The purpose of phase Ib CT was to evaluate the safety, tolerability, PK of PBTZ169, 80 mg capsule, after single, double and multiple administration under fasting conditions in increasing doses, as well as the effect of food on its bioavailability in healthy volunteers. Materials and methods. The data of 100 healthy volunteers and 15 patients with newly diagnosed pulmonary tuberculosis, who received the study medication PBTZ169, capsules 40 mg and 80 mg, in the dose range 40 mg 1280 mg of PBTZ169, obtained during phase I, IIa and Ib CTs were analyzed. During I phases CTs, safety, tolerability, and PK of the drug after a single and multiple administration under fasting condition and after meals at rising doses were evaluated. The safety assessment included evaluation of AE/SAE, vital signs, ECG results, and laboratory tests results in the safety population. In the course of phase IIa CT, in addition to safety, tolerance, and PK evaluation, the efficacy of the drug (in terms of EBA) using sputum culture on agar with CFU/ml counting (main method) and quantitative PCR method (auxiliary method) was evaluated. Results. During all CTs, a high safety and tolerability profile was shown, the main PK parameters of the drug and the efficacy were described. PBTZ169 demonstrated linear PK in the dosage range up to 640 mg after single and multiple administration, a statistically significant of EBA of the drug after monotherapy at the dose of 640 mg/day was demonstrate, and it was concluded that the preferred regimen of the drug PBTZ169 intake is administration after meals. Good tolerability and a favorable safety profile of the drug in the studied doses range were demonstrate during all the CTs. Conclusion. One of the most promising and currently studied drugs-inhibitors of DprE1, a new target for the cell wall of mycobacteria, is PBTZ169 or macozinone, which is being develop by the Russian pharmaceutical company NEARMEDIC PLUS ltd.

Marine Medicine

USE OF ADSORPTION OXYGEN CONCENTRATOR IN MEDICAL PRACTICE

作者: Vlasenko, P. O. ; Seryakov, D. N.

The article deals with the use of pure oxygen in medicine. In a comparative vein, the main ways of providing medical and prophylactic institutions with oxygen are considered, information on the requirements for modern equipment of specialized medical facilities and departments is provided. Those problematic aspects of a fatigue, which are regularly encountered by the heads of medical institutions, are highlighted, taking into account many factors that were not taken into account when the well-established work of the centralized supply of medical oxygen (climate, the transport component, the economic issue, the situation with competent technical personnel, document flow work in supervising institutions, etc.). The regulatory frameworks on the arrangement of various oxygen supply systems are presented. Information on safety requirements when working with liquid and gaseous oxygen in vessels under pressure is provided. With reference to the regulatory documentation, the point of view is stated that, taking into account modern economic and economic aspects, in a number of medical institutions, in addition to the traditional-cryogenic method of obtaining medical oxygen, a short-cycle adsorption without heat is very often an expedient method of obtaining oxygen. This absorption allows to produce pure gas with relatively low pressure and ambient temperature directly at the place of the gas consumption. The method of non-heating absorption is described, and information on design of the installation for the production of oxygen is given in detail. The technical characteristics of various types of oxygen concentrators of various production capacities are given.

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