A Phase 1 interventional study of NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally and NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day) in Smallpox, Monkeypox and Cowpox, sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Phase 1, Interventional, and Treatment
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:
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.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 90 is below the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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)
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
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)
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)
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
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Groups 1-6: at days 0, 1, 3, 7.
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.
Time frame: Groups 1-6: at days 0, 7.
Monitoring of the pharmacokinetic parameter "Cmax" 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Groups 1-3: at days 1-5; groups 4-6: at days 1-10.
Plan to share: No
Ran from Sep 2020 to primary completion in Feb 2021, 5 months.
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Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"