Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years

NCT05976100 | Completed Phase 1

• 1 other identifier: NIOCH-01/20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The Aim: To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using a set of clinical and laboratory-instrumental methods. The research tasks are to:

• to assess the safety and tolerability of different single doses of the drug;
• to assess the safety and tolerability of different repeated doses of the drug;
• to study pharmacokinetics of single and repeated administration of the drug;
• to assess the data on safety and tolerability to select the optimal drug dosing schedule to resolve the issue of conducting phase II clinical trial in an expanded cohort of volunteers.

Conditions

Smallpox; Monkeypox; Cowpox; Vaccinia Virus Infection

Keywords

Оrthopoxviruses; Smallpox; NIOCH-14; Сlinical study

Outcome Measures

Primary Outcomes (39)

• Monitoring of erythrocyte level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: erythrocyte level is measured (10\^12 pcs/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of leukocyte level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: leukocyte level is measured (10⁹ pcs/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of platelet level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: platelet level is measured (10⁹ pcs/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of hemoglobin level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: hemoglobin level is measured (g/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of erythrocyte sedimentation rate (ESR) (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: ESR is measured (mm/hr). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of stab neutrophil level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: stab neutrophil level is measured (%). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of segmented neutrophil level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: segmented neutrophil level is measured (%). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of eosinophil level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: eosinophil level is measured (%). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of basophil level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: basophil level is measured (%). Value changes between time points are calculated. 10\. Monitoring of monocyte level (in clinical (general) blood test).

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of monocyte level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: monocyte level is measured (%). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of lymphocyte level (in clinical (general) blood test).

  On control days, a clinical (general) blood test is performed: lymphocyte level is measured (%). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of alanine transaminase activity (in biochemical blood test).

  On control days, a biochemical blood test is performed: the activity of alanine transaminase is measured (U/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of aspartate aminotransferase activity (in biochemical blood test).

  On control days, a biochemical blood test is performed: the activity of aspartate aminotransferase is measured (U/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of alkaline phosphatase activity (in biochemical blood test).

  On control days, a biochemical blood test is performed: the activity of alkaline phosphatase is measured (U/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of total protein level (in biochemical blood test).

  On control days, a biochemical blood test is performed: total protein level is measured (g/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of total bilirubin level (in biochemical blood test).

  On control days, a biochemical blood test is performed: total bilirubin level is measured (μmol/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of glucose level (in biochemical blood test).

  On control days, a biochemical blood test is performed: glucose level is measured (μmol/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of creatinine level (in biochemical blood test).

  On control days, a biochemical blood test is performed: creatinine level is measured (μmol/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of urea level (in biochemical blood test).

  On control days, a biochemical blood test is performed: urea level is measured (μmol/l). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of thymol test values (in biochemical blood test).

  On control days, a biochemical blood test is performed: thymol test value is measured (S-H). Value changes between time points are calculated

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of C-reactive protein (CRP) level (in biochemical blood test).

  On control days, a biochemical blood test is performed: CRP level is measured (mg/ml). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of prothrombin index (PTI) (in biochemical blood test).

  On control days, a biochemical blood test is performed: PTI is measured (%). Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of urine color (in common urine analysis).

  On control days, a common urine analysis is performed: urine color is assessed. Urine color changes between time points are evaluated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of urine transparency (in common urine analysis).

  On control days, a common urine analysis is performed: urine transparency is assessed. Urine transparency changes between time points are evaluated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of urine pH (in common urine analysis).

  On control days, a common urine analysis is performed: urine pH is measured. Urine pH changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of urine specific density (in common urine analysis).

  On control days, a common urine analysis is performed: urine specific density is measured. Urine specific density changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of protein level (in common urine analysis).

  On control days, a common urine analysis is performed: protein level (g/l) is measured. Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of glucose level (in common urine analysis).

  On control days, a common urine analysis is performed: glucose level (μmol/l) is measured. Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of leukocyte level (in common urine analysis).

  On control days, a common urine analysis is performed: leukocyte level (10⁹/l) is measured. Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of erythrocyte level (in common urine analysis).

  On control days, a common urine analysis is performed: erythrocyte level (10\^12 /l) is measured. Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring of bacteria (in common urine analysis).

  On control days, a common urine analysis is performed: bacterial number (units per field) is measured. Value changes between time points are calculated.

  Groups 1-6: at days 0, 3, 7, 10, 20, 30, 90.

• Monitoring for the occurrence of adverse events and serious adverse events at least likely related to the studied drug during the study.

  At each visit, the occurrence of adverse events and serious adverse events, at least likely related to the studied drug, is monitored. The change in the volunteer's state between time points is evaluated.

  Groups 1-6: at days 2-10, 20, 30, 90.

• Monitoring for the occurrence of any adverse events during the study.

  At each visit, the incidence of any adverse events is measured. The change in the volunteer's state between time points is evaluated.

  Groups 1-6: at days 2-10, 20, 30, 90.

• Monitoring for the occurrence of any serious adverse events during the study.

  At each visit, the incidence of any serious adverse events that lead to the exclusion of participant from the study is measured. The change in the volunteer's state between time points is evaluated.

  Groups 1-6: at days 2-10, 20, 30, 90.

• Monitoring of body temperature at regular intervals.

  Body temperature is recorded (degrees Celsius, °C) on control days. Changes in the values of this parameter between time points are calculated.

  Groups 1-6: at days 0, 1-10, 20, 30, 90.

• Monitoring of blood pressure at regular intervals.

  Systolic and diastolic blood pressure is recorded (mm Hg). Changes in the values of this parameter between time points are calculated.

  Groups 1-6: at days 0, 1-10, 20, 30, 90.

• Monitoring of heart rate at specified intervals.

  Heart rate is recorded (beats per minute) on control days. Changes in the values of this parameter between time points are calculated.

  Groups 1-6: at days 0, 1-10, 20, 30, 90.

• Monitoring of respiratory movement frequency at specified intervals.

  On the control days, the frequency of respiratory movements (per minute) is recorded. Changes in the values of this parameter between time points are calculated.

  Groups 1-6: at days 0, 1-10, 20, 30, 90.

• Electrocardiography findings (ECG).

  On control days, a planned standard 12-lead ECG is performed (with measurement of heart rate \[HR\], PR, QRS, QT intervals and QTc calculation). It is performed in the supine position after 5 minutes of rest. The rhythm record in the respective leads must contain measurable data for at least three cardiac cycles. Changes in the values between time points are calculated. If there are any changes in the ECG, the clinical investigator should evaluate their clinical significance.

  Groups 1-6: at days 0, 1, 3, 7.

Secondary Outcomes (7)

• Abdominal ultrasound findings.

  Groups 1-6: at days 0, 7.

• Monitoring of the pharmacokinetic parameter "Cmax" for ST-246 (active metabolite of NIOCH-14)

  Groups 1-3: at days 1-5; groups 4-6: at days 1-10.

• Monitoring of the pharmacokinetic parameter "Tmax" for ST-246 (active metabolite of NIOCH-14)

  Groups 1-3: at days 1-5; groups 4-6: at days 1-10.

• Monitoring of the pharmacokinetic parameter "Cmax /AUC" for ST-246 (active metabolite of NIOCH-14)

  Groups 1-3: at days 1-5; groups 4-6: at days 1-10.

• Monitoring of the pharmacokinetic parameter "Elimination rate" for ST-246 (active metabolite of NIOCH-14)

  Groups 1-3: at days 1-5; groups 4-6: at days 1-10.

Study Arms (6)

Group 1 (15 volunteers)

EXPERIMENTAL

Single use: Single 200-mg oral dose of NIOCH-14

Drug: NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally

Group 2 (15 volunteers)

EXPERIMENTAL

Single use: Single 600-mg oral dose of NIOCH-14

Drug: NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day)

Group 3 (15 volunteers)

EXPERIMENTAL

Single use: Single 1200-mg oral dose of NIOCH-14 (on the same day in the morning 600 mg and in the evening 600 mg)

Drug: NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day)

Group 4 (15 volunteers)

EXPERIMENTAL

Multiple application: Daily 200-mg oral dose of NIOCH-14 once a day for 6 days

Drug: NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days

Group 5 (15 volunteers)

EXPERIMENTAL

Multiple application: Daily 600-mg oral dose of NIOCH-14 once a day for 6 days

Drug: NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 a day orally for 6 days. (Total 600 mg NIOCH-14 per day for 6 days)

Group 6 (15 volunteers)

EXPERIMENTAL

Multiple application: Daily 600-mg oral dose of NIOCH-14 twice a day for 6 days

Drug: NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days. (Total 1200 mg NIOCH-14 per day for 6 days)

Interventions

NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally DRUG

Volunteers take 1 capsule (200 mg) of NIOCH-14 as a single oral dose.

Also known as: 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule

Group 1 (15 volunteers)

NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day) DRUG

Volunteers take 3 capsules (200 mg each) of NIOCH-14 as a single oral dose. (Total 600 mg NIOCH-14 per day)

Also known as: 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule

Group 2 (15 volunteers)

NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day) DRUG

Single 1200-mg oral dose. (1200-mg dose of the drug is administered by 600 mg twice a day at 8-00 and 20-00 in the hospital and presence of a clinical investigator or a nurse).

Also known as: 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule

Group 3 (15 volunteers)

NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days DRUG

Volunteers take 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days.

Also known as: 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule

Group 4 (15 volunteers)

NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 a day orally for 6 days. (Total 600 mg NIOCH-14 per day for 6 days) DRUG

Volunteers take 3 capsules (200 mg each) of NIOCH-14 a day orally for 6 days.

Also known as: 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule

Group 5 (15 volunteers)

NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days. (Total 1200 mg NIOCH-14 per day for 6 days) DRUG

Volunteers take 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days.

Also known as: 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule

Group 6 (15 volunteers)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated informed consent of a volunteer to participate in the clinical study, obtained prior to any of the study procedures.
• A verified diagnosis "healthy" based on findings of standard clinical, laboratory and instrumental methods of examination.
• Age from 18 to 50 years inclusive.
• Body mass index from 18.5 to 30 kg/m3.
• Ability to attend all scheduled visits and all scheduled procedures and examinations.
• Consent of volunteers to use effective methods of contraception throughout the study.

You may not qualify if:

• Known hypersensitivity to any component of the studied drug.
• Aggravated history of allergies.
• Drug intolerance.
• Pregnancy and the period of breastfeeding.
• Military personnel.
• Persons in custody in pre-trial detention centers and serving sentences in penitentiaries.
• Children's age under 18.
• Acute infectious diseases less than 4 weeks before the start of the study.
• Acute or chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, blood, kidneys, surgical interventions to the gastrointestinal tract (with the exception of appendectomy).
• Immunosuppressive conditions: congenital or acquired immunodeficiency syndrome (including HIV infection), leukemia, malignant tumors, organ transplantation, cellular and humoral immunodeficiencies.
• Immunosuppressive therapy: treatment with antimetabolites, high doses of corticosteroids for 14 days or more, radio and x-ray therapy, etc.
• Regular medication intake less than 2 weeks prior to the start of the study.
• Taking medications that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before the start of the study.
• Donation (450 ml of blood or plasma or more) less than 2 months before the start of the study.
• Participation in other clinical trials less than 3 months prior to study enrollment.

Sponsors & Collaborators

• Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector": lead

Study Sites (1)

Federal State Budgetary Healthcare Institution - Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency (FGBUZ MSCH-163, FMBA Russia)

Novosibirsk, Koltsovo, Novosibirsk Region, 630559, Russia

Location

Related Publications (21)

• Campe H, Zimmermann P, Glos K, Bayer M, Bergemann H, Dreweck C, Graf P, Weber BK, Meyer H, Buttner M, Busch U, Sing A. Cowpox virus transmission from pet rats to humans, Germany. Emerg Infect Dis. 2009 May;15(5):777-80. doi: 10.3201/eid1505.090159.

  PMID: 19402967 BACKGROUND

• Ladnyi I.D. Eradication of Smallpox and Prevention of Its Recurrence. - Moscow: Meditsina, 1985. - 224 P.

  BACKGROUND

• Fenner F., Henderson D.A., Arita I., et al. Smallpox and its eradication. - Geneva: World Health Organization, 1988.

  BACKGROUND

• Scientific review of variola virus research, 1999-2010//WHO/HSE/GAR/BDP/2010.3. December 2010

  BACKGROUND

• Borisevich SV, Marennikova SS, Makhlay AA, Terent'ev AI, Loginova SY, Perekrest VV, Krasnyanskiy VP, Bondarev VP, Rybak SI Cowpox: spread features after the abolition of mandatory smallpox vaccination. Journal of microbiology, epidemiology and immunobiology. 2012; N. 3. 103-107.

  BACKGROUND

• Hemmer CJ, Littmann M, Lobermann M, Meyer H, Petschaelis A, Reisinger EC. Human cowpox virus infection acquired from a circus elephant in Germany. Int J Infect Dis. 2010 Sep;14 Suppl 3:e338-40. doi: 10.1016/j.ijid.2010.03.005. Epub 2010 Jun 26.

  PMID: 20580588 BACKGROUND

• Ninove L, Domart Y, Vervel C, Voinot C, Salez N, Raoult D, Meyer H, Capek I, Zandotti C, Charrel RN. Cowpox virus transmission from pet rats to humans, France. Emerg Infect Dis. 2009 May;15(5):781-4. doi: 10.3201/eid1505.090235.

  PMID: 19402968 BACKGROUND

• Baran V.M., Zubritsky P.K. Human cowpox. Healthcare (Minsk). 1997; No. 3. P. 40

  BACKGROUND

• Marennikova SS, Gashnikov PV, Zhukova OA, Riabchikova EI, Strel'tsov VV, Riazankina OI, Chekunova EV, Ianova NN, Shchelkunov SN. [The biotype and genetic characteristics of an isolate of the cowpox virus causing infection in a child]. Zh Mikrobiol Epidemiol Immunobiol. 1996 Jul-Aug;(4):6-10. Russian.

  PMID: 9027179 BACKGROUND

• Shchelkunov SN. Emergence and reemergence of smallpox: the need for development of a new generation smallpox vaccine. Vaccine. 2011 Dec 30;29 Suppl 4:D49-53. doi: 10.1016/j.vaccine.2011.05.037. Epub 2011 Dec 18.

  PMID: 22185833 BACKGROUND

• Shchelkunov SN. An increasing danger of zoonotic orthopoxvirus infections. PLoS Pathog. 2013;9(12):e1003756. doi: 10.1371/journal.ppat.1003756. Epub 2013 Dec 5.

  PMID: 24339772 BACKGROUND

• Marennikova S.S., Shchelkunov S.N. Orthopoxviruses pathogenic to humans. M.: KMK Scientific Press Ltd. - 1998. - 385 P.

  BACKGROUND

• Onishchenko GG, Sandkhchiev LS, Netesov SV, Shchelkunov SV. [Bioterrorism: national and global threats]. Zh Mikrobiol Epidemiol Immunobiol. 2000 Nov-Dec;(6):83-5. No abstract available. Russian.

  PMID: 11210651 BACKGROUND

• Yang G, Pevear DC, Davies MH, Collett MS, Bailey T, Rippen S, Barone L, Burns C, Rhodes G, Tohan S, Huggins JW, Baker RO, Buller RL, Touchette E, Waller K, Schriewer J, Neyts J, DeClercq E, Jones K, Hruby D, Jordan R. An orally bioavailable antipoxvirus compound (ST-246) inhibits extracellular virus formation and protects mice from lethal orthopoxvirus Challenge. J Virol. 2005 Oct;79(20):13139-49. doi: 10.1128/JVI.79.20.13139-13149.2005.

  PMID: 16189015 BACKGROUND

• Burgasov P.N., Nikolaevsky G.P. Smallpox. - M.: Medicine, 1972. - 207 P.

  BACKGROUND

• Mazurkov OY, Kabanov AS, Shishkina LN, Sergeev AA, Skarnovich MO, Bormotov NI, Skarnovich MA, Ovchinnikova AS, Titova KA, Galahova DO, Bulychev LE, Sergeev AA, Taranov OS, Selivanov BA, Tikhonov AY, Zavjalov EL, Agafonov AP, Sergeev AN. New effective chemically synthesized anti-smallpox compound NIOCH-14. J Gen Virol. 2016 May;97(5):1229-1239. doi: 10.1099/jgv.0.000422. Epub 2016 Feb 8.

  PMID: 26861777 BACKGROUND

• Mazurkov OY, Shishkina LN, Bormotov NI, Skarnovich MO, Serova OA, Mazurkova NA, Chernonosov AA, Tikhonov AY, Selivanov BA. Estimation of Absolute Bioavailability of the Chemical Substance of the Anti-Smallpox Preparation NIOCH-14 in Mice. Bull Exp Biol Med. 2020 Dec;170(2):207-210. doi: 10.1007/s10517-020-05034-x. Epub 2020 Dec 2.

  PMID: 33263846 BACKGROUND

• Selivanov B.A., et al. 7-[N'-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo[3.2.2.02,4]non-8-ene-6-carboxylic acid, having antiviral activity. Patent RU No. 2412160, publ. 20.02.2011, Bull. No. 5.

  BACKGROUND

• Shishkina L.N., Sergeev A.N., Agafonov A.P., Sergeev A.A., Kabanov A.S., Bulychev L.E., Sergeev A.A., Galakhova D.O., Pyankov O.V., Bormotov N.I., Shchukin G.I., Selivanov B.A., Tikhonov A.Ya. Medicated product for smallpox virus and method for producing and using it. Patent RU No. 2543338, publ. 02/27/2015, Bulletin No. 6.

  BACKGROUND

• Chen Y, Amantana A, Tyavanagimatt SR, Zima D, Yan XS, Kasi G, Weeks M, Stone MA, Weimers WC, Samuel P, Tan Y, Jones KF, Lee DR, Kickner SS, Saville BM, Lauzon M, McIntyre A, Honeychurch KM, Jordan R, Hruby DE, Leeds JM. Comparison of the safety and pharmacokinetics of ST-246(R) after i.v. infusion or oral administration in mice, rabbits and monkeys. PLoS One. 2011;6(8):e23237. doi: 10.1371/journal.pone.0023237. Epub 2011 Aug 15.

  PMID: 21858040 BACKGROUND

• van Gerven J, Bonelli M. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. Br J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30. No abstract available.

  PMID: 29451320 BACKGROUND

MeSH Terms

Conditions

Smallpox; Mpox, Monkeypox; Cowpox

Interventions

NIOCH-14

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Vladimir I. Kuzubov, PhD

  FGBUZ MSCH-163, FMBA Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: August 4, 2023
• Study Start: September 4, 2020
• Primary Completion: February 27, 2021
• Study Completion: March 9, 2022
• Last Updated: August 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)