PharyngitisPhase 1NCT06857890
Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers
A Phase 1 study testing Grammidin with anesthetic neo and Grammidin with anesthetic, a metered dose topical spray in people with Pharyngitis, run by Valenta Pharm JSC at 1 site in Russia.
Trial summary
This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Grammidin with anesthetic neo and Grammidin with anesthetic, a metered dose topical spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 9 Dec 2024to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;
- Males and females aged 18 to 45 years (inclusive);
- Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical examination, laboratory tests, and other diagnostic procedures specified in the protocol;
- Blood pressure (BP) level: systolic blood pressure (SBP) from 99 to 129 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);
- Heart rate (HR) from 60 to 89 beats per minute (inclusive);
- Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);
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- Body temperature from 36.0°C to 36.9°C (inclusive);
- Body mass index (BMI) between 18.5 kg/m² and 30 kg/m², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women;
- Consent to use adequate contraceptive methods throughout the study and for 30 days after its completion, with a negative urine pregnancy test result for women of childbearing potential.
- Non-Inclusion Criteria:
- Clinically significant allergic history;
- Hypersensitivity to active and/or excipient substances in the investigational drug and comparator drug in the medical history;
- Drug intolerance to active and/or excipient substances in the investigational drug and comparator drug in the medical history;
- Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic organs, and the eye;
- Erosive-ulcerative lesions of the oral mucosa (aphthous stomatitis, mechanical trauma due to dental diseases, herpes lesions, and any other condition resulting in compromised integrity of the oral mucosa);
- Surgical interventions on the GIT in the medical history (except for appendectomy performed at least 1 year prior to screening);
- Diseases/conditions that, in the investigator's judgment, may affect the absorption, distribution, metabolism, or excretion of the investigational drugs;
- Acute infectious diseases less than 4 weeks before screening;
- Use of medications (drugs) that significantly affect hemodynamics and drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;
- Regular use of medications less than 2 weeks before screening and single use of medications less than 7 days before screening (including over-the-counter medications, vitamins, dietary supplements, herbal medicines);
- Blood or plasma donating within 3 months prior to screening;
- Use of hormonal contraceptives (in women) within 2 months prior to screening;
- Use of depot injections of any medications within 3 months prior to screening;
- Pregnancy or lactation; positive urine pregnancy test result for women of childbearing potential;
- Female subjects of childbearing potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days prior to administration investigational drugs;
- Participation in another clinical study within 3 months prior to screening or concurrently with this study;
- Consumption of more than 10 alcohol units per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine, or 50 ml of strong alcoholic beverages) in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse;
- Smoking more than 10 cigarettes per day currently or smoking that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during hospitalization;
- Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking investigational drugs;
- Consumption of citrus fruits, cranberries, rose hips and products containing them, or preparations/products containing St. John's wort within 7 days prior to taking investigational drugs;
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to taking investigational drugs;
- Positive blood test for antibodies to human immunodeficiency virus (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens during screening;
- Positive rapid test for SARS-CoV-2 at screening;
- ECG abnormalities in medical history and/or during screening;
- Positive urine test for narcotic substances and potent medications during screening;
- Positive breath alcohol test result during screening;
- Planning hospitalization during the study period for any reason other than hospitalization specified in this protocol;
- Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, or adhere to dietary and activity restrictions;
- Membership in a vulnerable population? including but not limited to students of medical, pharmaceutical and dental educational institutions, junior staff of clinics and laboratories, employees of pharmaceutical companies, military personnel, prisoners, residents of care facillities, individuals with low income or unemployed, members of ethnic minorities, homeless persons, vagrants, refugees, individuals under guardianship or conservatorship, ndividuals unable to provide informed consent and law enforcement personnel;
- Dental procedures performed within 3 weeks prior to screening;
- Other conditions that in the judgment of the Investigator may prevent volunteer inclusion in the study or lead to premature withdrawal from the study including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or special lifestyles (night work, extreme physical exertion).
Who cannot join
- Withdrawal of the volunteer from further participation in the study;
- Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
- Emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
- Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria;
- Development of a severe adverse event (SAE) in the volunteer during the study;
- The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;
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- Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;
- Occurrence of vomiting/diarrhea within 6 hours after taking the investigational drug;
- Positive urine test for narcotic substances and potent medications;
- Positive breath test for alcohol vapors;
- Positive pregnancy test result in women;
- Positive SARS-CoV-2 test result;
- Emergence of other reasons during the study that prevent conducting the study according to the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Separate Medical Unit "CoMed" (LLC "Ligand Research")
Moscow
Irina Rodukova, MD, +7-499-444-33-72, info@comed.ru
About this study
Official title: An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of the Drug Grammidin With Anesthetic, a Metered Dose Topical Spray Following Single Administration in Healthy Volunteers
This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers.
- Conditions
- Pharyngitis
- Being tested
- Grammidin with anesthetic neo, Grammidin with anesthetic, a metered dose topical spray
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grammidin with anesthetic neoDrug
Also called gramicidin s, cetylpyridinium chloride, oxybuprocaine
Grammidin with anesthetic neo, lozenges, 1 lozenge to be taken once under fed conditions.
Grammidin with anesthetic, a metered dose topical sprayDrug
Also called gramicidin s, cetylpyridinium chloride, oxybuprocaine
Grammidin with anesthetic, a metered dose topical spray, 4 sprays to be taken once under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| RT sequence: Grammidin with anesthetic neo followed by Grammidin with anesthetic | Experimental | RT sequence where R is Grammidin with anesthetic neo, lozenges, and T is Grammidin with anesthetic, a metered dose topical spray Receives: Drug: Grammidin with anesthetic neo; Drug: Grammidin with anesthetic, a metered dose topical spray |
| TR sequence: Grammidin with anesthetic followed by Grammidin with anesthetic neo | Experimental | TR sequence where T is Grammidin with anesthetic, a metered dose topical spray, and R is Grammidin with anesthetic neo, lozenges Receives: Drug: Grammidin with anesthetic neo; Drug: Grammidin with anesthetic, a metered dose topical spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of gramicidin S, oxybuprocaine hydrochloride, and cetylpyridinium chloride. The same analytes would be used for other pharmacokinetic measures listed below.
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - tmax
Time to reach Cmax (tmax)
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: From 0 hours after each drug intake (extrapolated to infinity)
Pharmacokinetics - AUCextr
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Measured: From 0 hours after each drug intake (extrapolated to infinity)
Pharmacokinetics - t1/2
Elimination half-life (t1/2)
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - kel
Elimination constant (kel)
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - MRT
Mean residence time (MRT)
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - Vd
Volume of distribution
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - CL
Clearance (CL)
Measured: From 0 to 24 hours after each drug intake.
Pharmacokinetics - number of terminal timepoints
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
Measured: From 0 to 24 hours after each drug intake.
Secondary outcomes (55)
Adverse event type
Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.
Measured: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event number
Number of adverse events registered during the study
Measured: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event severety
Severity of adverse events registered during the study
Measured: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Drop-outs associated with adverse events
The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug
Measured: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Safety and Tolerability: volunteer complaints
Description of complaints, recieved from volunteer
Measured: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Safety and Tolerability: physical examination results - cardiovascular system
An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - respiratory system
An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - digestive tract
An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - endocrine system
An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - musculoskeletal system
An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - nervous system
An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - sensory systems
An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - skin/visible mucous membranes
An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - systolic blood pressure
Systolic blood pressure (SBP, mmHg)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - diastolic blood pressure
Diastolic blood pressure (DBP, mmHg)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - heart rate
Heart rate (HR, bpm)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)
Body temperature (Celsius temperature scale)
Measured: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)
Measured: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)
Measured: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)
Measured: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave)
Measured: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: clinical blood test - hemoglobin
Hemoglobin (g/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - hematocrit
Hematocrit (%)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - red blood cell count
Red blood cell count (cells/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - platelet count
Platelet count (cells/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - leukocyte count
Leukocyte count (cells/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm/h)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - segmented neutrophils
Leukocyte formula (segmented neutrophils, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - eosinophils
Leukocyte formula (eosinophils, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - basophils
Leukocyte formula (basophils, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - protein
Protein concentration (g/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - glucose
Glucose concentration (mmol/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - red blood cells
Red blood cell content (number in sight)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - white blood cells
White blood cell content (number in sight)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - epithelial cells
Epithelial cell content (number in sight)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - casts
Presence of casts (Yes/No)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - mucus
Presence of mucus (Yes/No)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - bacteria
Presence of bacteria (Yes/No)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis (microscopy)
Microscopy of urine sediment is performed if it is present
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - glucose
Glucose concentration (mmol/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - protein
Total protein concentration (g/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - creatinine
Creatinine concentration (micromol/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Measured: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start9 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857890
- Sponsor's protocol ID
- GRM-01-07-2024
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of the Drug Grammidin With Anesthetic, a Metered Dose Topical Spray Following Single Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06857890
- Acronym / sponsor ID
- GRM-01-07-2024
- Conditions
- Pharyngitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT sequence: Grammidin with anesthetic neo followed by Grammidin with anesthetic | Experimental | Drug: Grammidin with anesthetic neo, Drug: Grammidin with anesthetic, a metered dose topical sprayRT sequence where R is Grammidin with anesthetic neo, lozenges, and T is Grammidin with anesthetic, a metered dose topical spray |
| TR sequence: Grammidin with anesthetic followed by Grammidin with anesthetic neo | Experimental | Drug: Grammidin with anesthetic neo, Drug: Grammidin with anesthetic, a metered dose topical sprayTR sequence where T is Grammidin with anesthetic, a metered dose topical spray, and R is Grammidin with anesthetic neo, lozenges |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (41 listed)
- Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;
- Males and females aged 18 to 45 years (inclusive);
- Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical examination, laboratory tests, and other diagnostic procedures specified in the protocol;
- Blood pressure (BP) level: systolic blood pressure (SBP) from 99 to 129 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);
- Heart rate (HR) from 60 to 89 beats per minute (inclusive);
Key exclusion criteria (13 listed)
- Withdrawal of the volunteer from further participation in the study;
- Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
- Emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
- Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria;
- Development of a severe adverse event (SAE) in the volunteer during the study;
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 |
|---|---|---|
| Grammidin with anesthetic neoAlso: gramicidin s, cetylpyridinium chloride, oxybuprocaineGrammidin with anesthetic neo, lozenges, 1 lozenge to be taken once under fed conditions. | Drug | RT sequence: Grammidin with anesthetic neo followed by Grammidin with anesthetic, TR sequence: Grammidin with anesthetic followed by Grammidin with anesthetic neo |
| Grammidin with anesthetic, a metered dose topical sprayAlso: gramicidin s, cetylpyridinium chloride, oxybuprocaineGrammidin with anesthetic, a metered dose topical spray, 4 sprays to be taken once under fed conditions | Drug | RT sequence: Grammidin with anesthetic neo followed by Grammidin with anesthetic, TR sequence: Grammidin with anesthetic followed by Grammidin with anesthetic neo |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 24 hours after each drug intake.
Maximum plasma concentration (Cmax) of gramicidin S, oxybuprocaine hydrochloride, and cetylpyridinium chloride. The same analytes would be used for other pharmacokinetic measures listed below.
Pharmacokinetics - tmax
Time frame: From 0 to 24 hours after each drug intake.
Time to reach Cmax (tmax)
Pharmacokinetics - AUC0-t
Time frame: From 0 to 24 hours after each drug intake.
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Pharmacokinetics - AUC0-inf
Time frame: From 0 hours after each drug intake (extrapolated to infinity)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Pharmacokinetics - AUCextr
Time frame: From 0 hours after each drug intake (extrapolated to infinity)
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Pharmacokinetics - t1/2
Time frame: From 0 to 24 hours after each drug intake.
Elimination half-life (t1/2)
Pharmacokinetics - kel
Time frame: From 0 to 24 hours after each drug intake.
Elimination constant (kel)
Pharmacokinetics - MRT
Time frame: From 0 to 24 hours after each drug intake.
Mean residence time (MRT)
Pharmacokinetics - Vd
Time frame: From 0 to 24 hours after each drug intake.
Volume of distribution
Pharmacokinetics - CL
Time frame: From 0 to 24 hours after each drug intake.
Clearance (CL)
Pharmacokinetics - number of terminal timepoints
Time frame: From 0 to 24 hours after each drug intake.
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
55 secondary outcomes
Adverse event type
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event number
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event severety
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Drop-outs associated with adverse events
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Safety and Tolerability: volunteer complaints
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Safety and Tolerability: physical examination results - cardiovascular system
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - respiratory system
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - digestive tract
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - endocrine system
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - musculoskeletal system
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - nervous system
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - sensory systems
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: physical examination results - skin/visible mucous membranes
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - systolic blood pressure
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - diastolic blood pressure
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - heart rate
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)
Time frame: Screeninig (days -14 to -1), day -1 to 2, day 7 to 9, day 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
Time frame: Screeninig (days -14 to -1), day 1, 2, 8, 9, 15 ± 1
Safety and Tolerability: clinical blood test - hemoglobin
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - hematocrit
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - red blood cell count
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - platelet count
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - leukocyte count
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - myelocytes
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - band neutrophils
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - segmented neutrophils
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - eosinophils
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - basophils
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - monocytes
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: clinical blood test - lymphocytes
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - specific gravity
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - color
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - transparency
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - pH
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - protein
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Safety and Tolerability: urinalysis - glucose
Time frame: Screeninig (days -14 to -1), day 2, 9, 15 ± 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
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 Grammidin with anesthetic neo and Grammidin with anesthetic, a metered dose topical spray in people with Pharyngitis, 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 41 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Cmax (time frame: From 0 to 24 hours after each drug intake.). The study lists 11 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 10 Jul 2025.