InfectionsPhase 1NCT05505097
Safety and Pharmacokinetics of Dioxidin, Solution for Topical and External Use, 0.25 mg/ml and Dioxidin, Solution for Infusion and External Use, 5 mg/ml in Healthy Volunteers
A Phase 1 study testing Hydroxymethylquinoxalindioxyde in people with Infections, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
The study aimed for: 1. To study the safety of the drug Dioxidin, solution for topical and external use; 2. To determine the concentrations of the active substance of the studied drugs Dioxidin, solution for topical and external use, and Dioxidin, solution for infusion and external use in discrete time intervals; 3. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Hydroxymethylquinoxalindioxyde
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 4 May 2022to 19 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study before any of the study procedures
- Age from 18 to 45 years (inclusive)
- Verified diagnosis "healthy" by standard clinical, laboratory, instrumental methods of examination
- Blood pressure level: systolic from 100 to 130 mmHg, diastolic from 60 to 90 mmHg (inclusive)
- Heart rate 60 to 90 beats per minute (inclusive)
- Body mass index (BMI) is 18.5 ≤ BMI ≤ 30.0 kg/m², with a body weight of ≥55 kg for men and ≥45 kg for women
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- Volunteers must behave appropriately, coherent speech must be observed
- For women of childbearing potential, negative pregnancy test; consent of volunteers to either abstain from sexual intercourse or use a dual barrier method of contraception for the duration of study participation, beginning with the Screening Period, and for 3 weeks after study termination
- Ability to follow the daily routine and dietary regimen of the study protocol
- Ability to attend all scheduled appointments and stay at the Research Center for all Study Periods
Who cannot join
- A history of allergic reactions
- A history of drug intolerance to the active and/or excipients in the study medications
- Inability to successfully perform oropharyngeal rinse test
- Any chronic illnesses
- History of gastrointestinal surgery (except appendectomy)
- Acute infectious diseases less than 4 weeks prior to screening
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- Taking medications that significantly affect hemodynamics and medications that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening
- Regularly taking medications less than 2 weeks before screening and taking a single medication 7 days before screening
- Donating blood (450 mL of blood or plasma or more) less than 3 months before screening
- For women, the last intake of oral contraceptives at least 2 months prior to screening
- Pregnant and lactating women, and women and men of childbearing age who cannot or do not abstain from sexual intercourse or use a dual barrier method of contraception for the duration of study participation, beginning with the Screening Period, and for 3 weeks after the study ends
- Participation in another clinical trial less than 3 months before screening or concurrently with this study
- Taking more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine, or 40 ml of spirits) in the week in the last month before inclusion in the study or anamnestic evidence of alcoholism, drug abuse, or medication abuse
- Smoking more than 10 cigarettes per day currently, or a history of smoking this number of cigarettes in the 6 months prior to screening
- A positive blood test for HIV, syphilis, hepatitis B/C
- A positive urine test for narcotics and powerful drugs
- Positive breath alcohol test
- Positive COVID-19 test
- Scheduled inpatient hospitalization during the study for any reason other than hospitalization as required by this protocol
- Inability or inability to meet the requirements of the protocol, including for physical, mental or social reasons, in the opinion of the Researcher
- Work/study regimen that is likely to make it impossible for the volunteer to complete the study and/or comply with the schedule of procedures
- Other conditions that, in the opinion of the Researcher, prevent the inclusion of the volunteer in the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Limited Liability Company "X7 Clinical Research"
Saint Petersburg, 194156
About this study
Official title: Open Randomized Comparative Crossover Study of the Safety and Pharmacokinetics of Dioxidin, Solution for Topical and External Use, 0.25 mg/ml and Dioxidin, Solution for Infusion and External Use, 5 mg/ml in Healthy Volunteers
The study aimed for:
- To study the safety of the drug Dioxidin, solution for topical and external use;
- To determine the concentrations of the active substance of the studied drugs Dioxidin, solution for topical and external use, and Dioxidin, solution for infusion and external use in discrete time intervals;
- To study pharmacokinetics of the drug Dioxidin, solution for topical and external application;
- To determine the absolute bioavailability of the drug Dioxidine, solution for topical and external use.
- Conditions
- Infections
- Being tested
- Hydroxymethylquinoxalindioxyde
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxymethylquinoxalindioxydeDrug
Also called Dioxidin
Dioxidin (Hydroxymethylquinoxalindioxyde), solution for topical and external use, 0.25 mg/ml, applied as:
A - single rinsing of the oropharynx with 15.0 ml of the drug solution for at least 30 seconds B - single irrigation of the oropharynx by spraying the preparation 4 times with a spray nozzle C - irrigation of the skin on the back by spraying the preparation 4 times from a distance of 10 cm on 1% of the body surface using a spray nozzle and exposing the solution for 30 minutes or D - Dioxidin (Hydroxymethylquinoxalindioxyde), solution for infusion and external application, 5 mg/ml, single intravenous 5 mg/ml in 1 ml
| Study group | Role | What they receive |
|---|---|---|
| ABCD-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence A-B-C-D during the corresponding study periods 1, 2, 3, and 4 Receives: Drug: Hydroxymethylquinoxalindioxyde |
| BCDA-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence B-C-D-A during the corresponding study periods 1, 2, 3, and 4 Receives: Drug: Hydroxymethylquinoxalindioxyde |
| CDAB-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence C-D-A-B during the corresponding study periods 1, 2, 3, and 4 Receives: Drug: Hydroxymethylquinoxalindioxyde |
| DABC-sequence | Other | Hydroxymethylquinoxalindioxyde administration in a sequence D-A-B-C during the corresponding study periods 1, 2, 3, and 4 Receives: Drug: Hydroxymethylquinoxalindioxyde |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of Hydroxymethylquinoxalindioxyde (HMQD)
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - tmax
Time to reach Cmax (tmax) of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - tlag
Time from administration to first accessible concentration of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - Vd
Volume of distribution of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - AUCextr
Extrapolated AUC of HMQD, defined as (AUC0-inf - AUC0-t)/AUC0-inf
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - kel
Elimination constant (kel) of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - t1/2
Elimination half-life (t1/2) of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Pharmacokinetics - MRT
Mean residence time (MRT) of HMQD
Measured: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Secondary outcomes (45)
Safety and Tolerability: adverse event (AE) rate
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to 43 days for each participant
Safety and Tolerability: serious adverse event (AE) rate
Number and frequency of serious AEs (SAEs)
Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to 43 days for each participant
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
SBP, mmHg
Measured: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
DBP, mmHg
Measured: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - respiratory rate (RR)
RR, breaths per minute
Measured: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - heart rate (HR)
HR, beats per minute
Measured: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - body temperature
Body temperature, centigrade scale
Measured: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: physical examination results
Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially.
Measured: Screening, -10 h, -1 h, 2 h, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)
Measured: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)
Measured: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)
Measured: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)
Measured: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - hemoglobin
Hemoglobin, g/dL
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - red blood cells
Red blood cells, 10^6/uL
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - hematocrit
Hematocrit, %
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - platelets
Platelets, 10^3/uL
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - white blood cells
White blood cells, 10^3/uL
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and at the end of the study or at early termination visit within the time frame of the study
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
Erythrocyte sedimentation rate, mm per hour
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - lymphocytes
Lymphocytes, %
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - eosinophils
Eosinophils, %
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - monocytes
Monocytes, %
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - basophils
Basophils, %
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - neutrophils
Neutrophils, % (segmented and stab)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - glucose
Glucose in blood serum, mmol/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - total cholesterol
Total cholesterol in blood serum, mmol/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - total protein
Total protein in blood serum, g/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - total bilirubin
Total bilirubin in blood serum, umol/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - creatinine
Creatinine in blood serum, umol/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
ALP in blood serum, U/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - alanine transaminase (ALT)
ALT in blood serum, U/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - aspartate transaminase (AST)
AST in blood serum, U/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - aldosterone
Aldosterone in blood serum, pmol/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - cortisol
Cortisol in blood serum, pmol/L
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and at the end of the study or at early termination visit within the time frame of the study
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - protein
Protein in the urine (g/L)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - glucose
Glucose in the urine (mmol/L)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Red blood cells in the urine (number in sight)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - white blood cells
White blood cells in the urine (number in sight)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - epithelial cells
Epithelial cells in the urine (number in sight)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - cylinders
Cylinders in the urine (number in sight)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - bacteria
Bacteria in the urine (number in sight)
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - mucus
Presence of mucus in the urine
Measured: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start4 May 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505097
- Sponsor's protocol ID
- DIO-01-04-2021
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Comparative Crossover Study of the Safety and Pharmacokinetics of Dioxidin, Solution for Topical and External Use, 0.25 mg/ml and Dioxidin, Solution for Infusion and External Use, 5 mg/ml in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05505097
- Acronym / sponsor ID
- DIO-01-04-2021
- Conditions
- Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed for:
- To study the safety of the drug Dioxidin, solution for topical and external use;
- To determine the concentrations of the active substance of the studied drugs Dioxidin, solution for topical and external use, and Dioxidin, solution for infusion and external use in discrete time intervals;
- To study pharmacokinetics of the drug Dioxidin, solution for topical and external application;
- To determine the absolute bioavailability of the drug Dioxidine, solution for topical and external use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABCD-sequence | Other | Drug: HydroxymethylquinoxalindioxydeHydroxymethylquinoxalindioxyde administration in a sequence A-B-C-D during the corresponding study periods 1, 2, 3, and 4 |
| BCDA-sequence | Other | Drug: HydroxymethylquinoxalindioxydeHydroxymethylquinoxalindioxyde administration in a sequence B-C-D-A during the corresponding study periods 1, 2, 3, and 4 |
| CDAB-sequence | Other | Drug: HydroxymethylquinoxalindioxydeHydroxymethylquinoxalindioxyde administration in a sequence C-D-A-B during the corresponding study periods 1, 2, 3, and 4 |
| DABC-sequence | Other | Drug: HydroxymethylquinoxalindioxydeHydroxymethylquinoxalindioxyde administration in a sequence D-A-B-C during the corresponding study periods 1, 2, 3, and 4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study before any of the study procedures
- Age from 18 to 45 years (inclusive)
- Verified diagnosis "healthy" by standard clinical, laboratory, instrumental methods of examination
- Blood pressure level: systolic from 100 to 130 mmHg, diastolic from 60 to 90 mmHg (inclusive)
- Heart rate 60 to 90 beats per minute (inclusive)
Key exclusion criteria (22 listed)
- A history of allergic reactions
- A history of drug intolerance to the active and/or excipients in the study medications
- Inability to successfully perform oropharyngeal rinse test
- Any chronic illnesses
- History of gastrointestinal surgery (except appendectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxymethylquinoxalindioxydeAlso: DioxidinDioxidin (Hydroxymethylquinoxalindioxyde), solution for topical and external use, 0.25 mg/ml, applied as: A - single rinsing of the oropharynx with 15.0 ml of the drug solution for at least 30 seconds B - single irrigation of the oropharynx by spraying the preparation 4 times with a spray nozzle C - irrigation of the skin on the back by spraying the preparation 4 times from a distance of 10 cm on 1% of the body surface using a spray nozzle and exposing the solution for 30 minutes or D - Dioxidin (Hydroxymethylquinoxalindioxyde), solution for infusion and external application, 5 mg/ml, single intravenous 5 mg/ml in 1 ml | Drug | ABCD-sequence, BCDA-sequence, CDAB-sequence, DABC-sequence |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Maximum plasma concentration (Cmax) of Hydroxymethylquinoxalindioxyde (HMQD)
Pharmacokinetics - tmax
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Time to reach Cmax (tmax) of HMQD
Pharmacokinetics - tlag
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Time from administration to first accessible concentration of HMQD
Pharmacokinetics - Vd
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Volume of distribution of HMQD
Pharmacokinetics - AUC0-t
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of HMQD
Pharmacokinetics - AUC0-inf
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of HMQD
Pharmacokinetics - AUCextr
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Extrapolated AUC of HMQD, defined as (AUC0-inf - AUC0-t)/AUC0-inf
Pharmacokinetics - kel
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Elimination constant (kel) of HMQD
Pharmacokinetics - t1/2
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Elimination half-life (t1/2) of HMQD
Pharmacokinetics - MRT
Time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study
Mean residence time (MRT) of HMQD
45 secondary outcomes
Safety and Tolerability: adverse event (AE) rate
Time frame: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to 43 days for each participant
Safety and Tolerability: serious adverse event (AE) rate
Time frame: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to 43 days for each participant
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
Time frame: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
Time frame: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - respiratory rate (RR)
Time frame: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - heart rate (HR)
Time frame: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: vital signs - body temperature
Time frame: Screening, -10 h, -1 h, 2 h, 12, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: physical examination results
Time frame: Screening, -10 h, -1 h, 2 h, and 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Time frame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Time frame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Time frame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
Time frame: Screening and the end of the study or an early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - hemoglobin
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - red blood cells
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - hematocrit
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - platelets
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - white blood cells
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and at the end of the study or at early termination visit within the time frame of the study
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - lymphocytes
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - eosinophils
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - monocytes
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - basophils
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: complete blood count - neutrophils
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - glucose
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - total cholesterol
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - total protein
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - total bilirubin
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - creatinine
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - alanine transaminase (ALT)
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - aspartate transaminase (AST)
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - aldosterone
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: blood test results - cortisol
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and at the end of the study or at early termination visit within the time frame of the study
Safety and Tolerability: urinalysis - specific gravity
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - color
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - transparency
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - pH
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - protein
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis - glucose
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Time frame: Screening, 24 h after each drug application on day 1, 7, 14, and 21 of the study, and on the end-of-study visit or on the early termination visit, whichever came first, within 43 days of study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxymethylquinoxalindioxyde in people with Infections, run by Valenta Pharm JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Cmax (time frame: From 0 to 16 hours after each drug application on day 1, 7, 14, and 21 of the study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.