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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:
An open, simple, randomized study of the safety, tolerability, and pharmacokinetics of NIOCH-14 in volunteers aged 18-50 years in parallel groups will be conducted.
The study included 90 healthy volunteers of both sexes aged 18-50 years who met the inclusion criteria, had no exclusion criteria and underwent all screening procedures.
Grouping of the volunteers:
1) For a single dose of the drug, three groups will be formed: group 1 - 15 volunteers, single 200-mg oral dose; group 2 - 15 volunteers, single 600-mg oral dose; group 3 - 15 volunteers, single 1200-mg oral dose. Before drug administration, volunteers should be hospitalized for a day in the hospital of Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ MSCH-163, FMBA Russia).
The drug will be first given to 5 healthy volunteers in Group 1. The volunteers will be followed up daily by a clinical investigator for 7 days. In the absence of changes in clinical analyzes and adverse events and the approval of the findings by the IDMC, the remaining subjects in Group 1 will begin to receive the drug.
After 7 days of the follow-up, the first 5 volunteers in Group 2 (600 mg) will start receiving the drug. After 7 days, the remaining 10 volunteers in Group 2 will receive the drug.
The first 5 volunteers in Group 3 will start receiving the drug after obtaining the results for the volunteers in Group 2.
If the volunteers feel satisfactory, they will be discharged on the 2nd day, and then will have to visit the clinical site for examination and identification of adverse events daily for 7 days, after which all volunteers will be given self- monitoring diaries for self-completion to record all adverse events. The volunteers have to present for examination and clinical testing on the 10th, 20th, 30th and 90th day after receiving the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (15 volunteers) | Experimental | Single use: Single 200-mg oral dose of NIOCH-14 |
|
| Group 2 (15 volunteers) | Experimental | Single use: Single 600-mg oral dose of NIOCH-14 |
|
| 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) |
|
| Group 4 (15 volunteers) | Experimental | Multiple application: Daily 200-mg oral dose of NIOCH-14 once a day for 6 days |
|
| Group 5 (15 volunteers) | Experimental | Multiple application: Daily 600-mg oral dose of NIOCH-14 once a day for 6 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal ultrasound findings. | On control days, the absence of signs of abdominal organ changes is monitored using ultrasound. Changes in the values between time points are calculated. | Groups 1-6: at days 0, 7. |
| Monitoring of the pharmacokinetic parameter "Cmax" for ST-246 (active metabolite of NIOCH-14) |
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Inclusion Criteria:
Exclusion Criteria:
Early (premature) exclusion of subjects from the study (reasons for discontinuation of the studied drug administration):
After randomization and the start of the clinical phase, a clinical investigator may exclude a subject early from the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I. Kuzubov, PhD | FGBUZ MSCH-163, FMBA Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19402967 | Background | 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. | |
| 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 | ||
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| Group 6 (15 volunteers) | Experimental | Multiple application: Daily 600-mg oral dose of NIOCH-14 twice a day for 6 days |
|
|
| 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) |
|
|
| 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). |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
On control days, blood concentration of the active NIOCH-14 metabolite, namely ST-246, is determined using mass spectrometry. The maximum concentration of a substance in the blood plasma, achieved after substance absorption (pharmacokinetic parameter Cmax) is measured. Changes in the values of this parameter between time points are calculated. |
| 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) | On control days, blood concentration of the active NIOCH-14 metabolite, namely ST-246, is determined using mass spectrometry. The pharmacokinetic parameter Tmax (the time point when the maximum concentration of a substance in the blood is reached) is measured. Changes in the values of this parameter between time points are calculated. | 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) | On control days, blood concentration of the active NIOCH-14 metabolite, namely ST-246, is determined using mass spectrometry. The pharmacokinetic parameter "Cmax /AUC" (the rate of substance entry into the systemic circulation from the injection site) is measured. Changes in the values of this parameter between time points are calculated. | 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) | On control days, blood concentration of the active NIOCH-14 metabolite, namely ST-246, is determined using mass spectrometry. The pharmacokinetic parameter "Elimination rate" (the rate of substance elimination from systemic circulation through biotransformation (metabolism) in the body, and excretion) is measured. Changes in the values of this parameter between time points are calculated. | Groups 1-3: at days 1-5; groups 4-6: at days 1-10. |
| Monitoring of the pharmacokinetic parameter "T½" for ST-246 (active metabolite of NIOCH-14) | On control days, blood concentration of the active NIOCH-14 metabolite, namely ST-246, is determined using mass spectrometry. The pharmacokinetic parameter "T½" (half-life, the time of 50% substance concentration reduction in plasma) is measured. Changes in the values of this parameter between time points are calculated. | Groups 1-3: at days 1-5; groups 4-6: at days 1-10. |
| Monitoring of the pharmacokinetic parameter "AUC" for ST-246 (active metabolite of NIOCH-14) | On control days, blood concentration of the active NIOCH-14 metabolite, namely ST-246, is determined using mass spectrometry. The pharmacokinetic parameter "AUC" (area under the curve. It is the integral parameter that characterizes the total amount of a substance entering the blood) is measured. Changes in the values of this parameter between time points are calculated. | Groups 1-3: at days 1-5; groups 4-6: at days 1-10. |
| 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. |
| 20580588 | 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. |
| 19402968 | 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. |
| Background | Baran V.M., Zubritsky P.K. Human cowpox. Healthcare (Minsk). 1997; No. 3. P. 40 |
| 9027179 | 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. |
| 22185833 | 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. |
| 24339772 | 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. |
| Background | Marennikova S.S., Shchelkunov S.N. Orthopoxviruses pathogenic to humans. M.: KMK Scientific Press Ltd. - 1998. - 385 P. |
| Background | Onishchenko G.G., Sandakhchiev L.S., Netesov S.N., Martynyuk R.A. Bioterrorism: national and global threat. - URL: http://www.bio.su/old/press_2006jan_032r.htm. |
| 16189015 | 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. |
| Background | Burgasov P.N., Nikolaevsky G.P. Smallpox. - M.: Medicine, 1972. - 207 P. |
| 26861777 | 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. |
| 33263846 | 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. |
| 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. |
| 21858040 | 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. |
| 29451320 | 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. |
| ID | Term |
|---|---|
| D012899 | Smallpox |
| D045908 | Mpox, Monkeypox |
| D015605 | Cowpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018419 | Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000618192 | NIOCH-14 |
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