CoughPhase 1NCT07754279
Clinical Trial of the Safety and Tolerability of MMH-522 in Healthy Volunteers
A Phase 1 study testing MMH-522 in people with Cough, run by Materia Medica Holding at 1 site in Russia.
Trial summary
Open-label, non-comparative, non-randomized clinical trial of the safety and tolerability of the drug MMH-450 in healthy volunteers consisting of 4 consecutive stages Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- MMH-522
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 12 Feb 2026to 7 May 2026
- 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
- Males and females aged 18 to 45 years.
- A diagnosis of "healthy" was established by the examining physician based on a medical assessment , including medical history, vital signs, an objective examination, a 12-lead electrocardiogram, and laboratory test results.
- The body mass index ranges from 18.5 to 30 kg/m2 with a body weight over 50 kg.
- Availability of a participant information sheet and informed consent form for participation in the clinical trial, signed by the participant.
- Participants who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).
Who cannot join
- A history of significant diseases, in the investigator's opinion, that may interfere with achieving the study's objectives: renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases.
- Any condition that may affect the absorption of the drug in the oral cavity or gastrointestinal tract (e.g., gastric resection or other gastrointestinal surgery other than appendectomy).
- Hypersensitivity to any component of the drug used in treatment; a history of anaphylactic reactions to drugs or general allergic reactions that, in the opinion of the investigator, may affect the outcome of the study.
- Abnormalities in laboratory blood and urine tests (general clinical, biochemical, coagulogram, platelet aggregation parameters).
- Abnormal in vital signs parameters: systolic blood pressure <90 mmHg or >139 mmHg; diastolic blood pressure <60 mmHg or >89 mmHg; heart rate <50 bpm or >99 bpm, body temperature >37.0, saturation <95%.
- Any abnormal ECG changes, including HR < 50 or > 99 bpm, mean corrected PQ < 120 or > 200 ms, QT (QTcF) > 450 ms, QRS < 60 or > 120 ms. Abnormal PQRST patterns.
Show all 17Show fewer
- Donor blood donation (450 ml of blood or more) less than 3 months before the start of the study.
- Participation in other clinical trials within 3 months prior to inclusion in the study.
- Regular alcohol consumption exceeding 10 units of alcohol per week (where each unit is approximately equal to 25 ml of spirits or 250 ml of beer) during the 6 months prior to taking the study drug.
- Positive breath alcohol test.
- Smoking cigarettes, cigars, e-cigarettes, or vapes within 3 months prior to taking the study drug.
- A positive urine rapid test for narcotics and drugs (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamine, morphine, MDMA (ecstasy), tricyclic antidepressants).
- Positive test results for hepatitis B, C, HIV, or syphilis.
- Participants who, in the investigator's judgment, will not comply with the study drug administration instructions.
- Pregnancy, breastfeeding, or childbirth less than 3 months prior to study entry.
- A participant is a member of the center's research staff directly involved in the study and is an immediate family member of the researcher. Immediate family members are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted.
- The participant is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or an appointed official responsible for the conduct of the study, or their immediate family member.
Trial locations and contacts
1 site in 1 country.
Russia1 site
First Moscow State Medical University named after I.M. Sechenov/Center for Clinical Research of Drugs
Moscow, 119991
About this study
Official title: Open-label, Non-comparative, Non-randomized Clinical Trial of the Safety and Tolerability of MMH-522 in Healthy Volunteers
Open-label, non-comparative, non-randomized clinical trial of the safety and tolerability of the drug MMH-450 in healthy volunteers consisting of 4 consecutive stages
Read the detailed description
Screening (Days -7-0, Visit 0) After signing a patient information sheet (PIS) and an informed consent form (ICF), the participant undergoes a screening examination on an outpatient basis (Days -7-0): medical history collection, physical examination (height, weight, vital signs: blood pressure, heart rate, body temperature, saturation)), pregnancy test, 12-lead ECG, breath alcohol test, laboratory tests (express urine analysis for drugs and medications, general blood and urine tests, blood chemistry, coagulation test, platelet aggregation test, HIV test, RPR test, HBsAg, HCV), determination of compliance with the inclusion/non-inclusion criteria. If the participant meets the inclusion criteria/does not meet the non-inclusion criteria, he or she is included in the study. The screening period lasts no more than 7 days.
Hospital admission (Day 1, Visit 1.1-1.3) A participant who has passed screening, meets the inclusion criteria, and does not meet the non-inclusion criteria will be admitted to the hospital on Day 1. Admission will take place from 8:00 to 9:00, admission to the hospital on the evening before is allowed (at the discretion of the test facility staff and with the consent of the participant). During hospital admission, the trial participant undergoes an objective examination prior to administration of the study drug, including measuring body weight, vital signs, a breath alcohol test, a 12-lead ECG, a urine express analysis for drugs and medications, a pregnancy test, and blood sampling for the development of methods for detecting the active components of the MMH-522 drug.
The first dose of MMH-522 is administered in the hospital under the supervision of medical staff at 10:00 (±20 min) on Day 1. The investigator assesses local tolerability of the drug immediately after administration and 15 minutes after administration of the study drug (SD), assesses subjective sensations after administration of the SD. In case of gagging or spitting out the drug, the participant repeats the attempt to take the test drug. A total of up to 3 attempts are allowed. Failure to take the drug will be recorded in the primary documents, and the participant will be excluded from the study and replaced by another participant (a replacement participant).
One hour after the first administration of the study drug, the investigator repeats the objective examination, measures vital signs, performs a 12-lead ECG, and assesses the safety of the test therapy (record any possible AEs).
The 2nd, 3rd and 4th doses of the study drug on Day 1 will be administered at 14:00 (±20 min), 18:00 (±20 min) and 22:00 (±20 min), respectively. The investigator will assess local tolerability of the drug immediately after administration and 15 minutes after each administration of the SD, assess subjective sensations after administration of the SD.
Within 24 hours of administering the first dose of the study drug, the participant is monitored by medical staff; the investigator assesses the safety of the study therapy (records possible AEs).
At 24 hours (±30 min) after administration of the first dose of the study drug, a repeat examination is performed, including a physical examination with assessment of vital signs, 12-lead ECG, laboratory tests (complete blood count and urine analysis, blood biochemistry, coagulation tests, platelet aggregation test), blood sampling for the development of methods for detecting the active components of MMH-522. The investigator assesses the safety of the study therapy (records possible AEs). The duration of hospital stay for conducting the research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), and the duration of the visit on Day 8 will be no more than 3 hours. Participants will receive the same menu during their stay in the hospital.
Drug administration period (Days 2-7) At 8:00 am (±20 min) on Day 2, the study drug is administered under the supervision of medical staff. The investigator assesses local tolerability of the drug immediately after administration and 15 minutes after administration of the SD. Starting with the daytime administration of the study drug on Day 2 and up to and including Day 7, the participant independently takes the drug 4 times a day, approximately at equal intervals in the morning (8:00-9:00 am), afternoon (12:00-1:00 and 16:00-17:00), and evening (20:00-21:00), indicating the exact time of administration of the study drug in the electronic participant diary (EPD), and recording any deterioration of their condition in the EPD; the physician monitors completion of the diary. The participant takes the study drug for a total of 7 days.
Final visit (Day 8, Visit 2) On Day 8, the hospital visit is scheduled for approximately 8:00 to 9:00. The participant visits the hospital fasting, and the investigator performs a physical examination, oral cavity examination, assesses subjective sensations after administration of the SD, measures vital signs, performs a breath alcohol test, 12-lead ECG, and laboratory tests (express urine analysis for drugs and medications, general blood and urine tests, blood chemistry, coagulation test, platelet aggregation test), blood sampling for developing methods for detecting active components of MMH-522; assesses compliance. The investigator assesses the safety of the study therapy (records possible AEs). If necessary, participants may be supervised after completion of all research procedures on Day 8 for up to 1 hour.
Unscheduled visit It is conducted in the event of an AE. The study participant is invited to visit the medical center. The investigator collects complaints, performs a physical examination, oral cavity examination, assesses subjective sensations after administration of the SD, measures vital signs. During the visit, the investigator decides on the further tactics regarding continued participation in the study and the need to prescribe AE therapy on an outpatient or inpatient basis. The participant may enter data on the AE that has occurred in the EPD or report it to the physician.
Early termination visit A participant who meets at least one withdrawal criterion is considered to have terminated their participation in the trial early. During the visit, the final visit procedures are performed, including an objective examination, measurement of vital signs, a breath alcohol test, 12-lead ECG, laboratory tests (express urine test for drugs and medications, general clinical blood and urine tests, blood chemistry test, coagulation test, platelet aggregation test), blood sampling for the development of methods for detecting the active components of MMH-522. The investigator indicates the date of termination of participation in the primary documentation and CRF, the date of the last administration of the study drug, notes the fact of early termination of participation in the study, the day of the participant's early exclusion from the study, the reason, and information about the return of the drug.
Monitoring of MMH-522 administration outside of the participants' stay in the hospital All participants will receive a reminder to take the study drug daily (Days 2-7) four times a day at 7:50, 11:50, 15:50, and 19:50. If a participant does not enter information about taking the SD into the EPD before the established periods, the participant and the investigator will receive a repeat reminder.
After each dose of MMH-522, the participant records the exact time of administration in the EPD. The investigator monitors the administration of MMH-522 by analyzing the records in the EPD. If there is no record of MMH-522 administration, the investigator contacts the participant to clarify the reason for not taking the study drug and, if the participant continues to participate in the trial, reminds them of the need to take MMH-522.
Stages of the trial The trial will be conducted in four stages. The stages will be carried out sequentially. Each subsequent stage will begin after the completion of the previous one and the conclusion of the Independent Committee for Monitoring Safety and Patient Data (ICMSPD ) on the safety and tolerability of the course administration at stages 1-4; upon completion of stage 4, a report on the phase I trial will be prepared.
The criteria for transition to the next stage are as follows:
Absence of severe AEs (grade 3 and above, CTCAE 5.0, Appendix 1) related to the cardiovascular system, gastrointestinal tract, skin and subcutaneous adipose tissue, laboratory abnormalities (in clinical and biochemical blood tests) associated with the administration of the study drug, severe life-threatening allergic reactions (generalized urticaria, angioedema, anaphylaxis) requiring intensive care.
In the event of one severe grade AE at each stage (grade 3 and above, CTCAE 5.0) related to the study drug, and AEs related to the study drug that led to the participant's early withdrawal from the study, as well as when new data appear indicating any changes in the benefit-risk ratio, an unscheduled meeting of the ICMSPD is held and a decision is made on the further tactics for conducting/completing the trial. If a decision is made to continue the trial, the current stage is repeated with three more participants.
Participants are screened separately before each stage. Stage 1 Course administration, single dose: 1 tablet of MMH-522 4 times a day for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing.
Stage 2 Course administration, single dose: 2 tablets of MMH-522 (consecutive administration of tablets without interruption is allowed) 4 times a day for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing.
Stage 3 Course administration, single dose: 3 tablets of MMH-522 (consecutive administration of tablets without interruption is allowed) 4 times a day for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing.
Stage 4 Repeat study of the maximum tolerated dosage regimen of MMH-522 for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing at stage 4.
For each stage, replacement participants who have successfully completed the screening procedures will be invited along with the main participants. If one of the participants is unable to be admitted to the hospital and participate in the trial for any reason, the replacement participant becomes a full participant in the study and undergoes all procedures according to the protocol. If all planned participants of the relevant stage are admitted to the hospital and receive the first dose of the study drug, the replacement participant will be excluded from the study.
Blood sampling for the development of methods for detecting the active components of MMH-522 will be performed three times on an empty stomach: 1) on Day 1 before administering the first dose of the study drug, 2) 24 hours (±30 min) after the start of administering the study drug, 3) 7 days after therapy with the study drug.
Then, blood serum is frozen for subsequent storage and transportation at -200С to the laboratory of the clinical trial Sponsor.
- Conditions
- Cough
- Being tested
- MMH-522
- Keywords
- Healthy volunteers
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-522Drug
Per os, without food (at least 30 minutes before or after meals and any liquid). The tablet is kept in the mouth until completely dissolved. Duration of therapy - 7 days
| Study group | Role | What they receive |
|---|---|---|
| MMH-522 | Experimental | The trial will be conducted in four stages. The stages will be carried out sequentially.
Group 1 (stage 1): Course administration, single dose - 1 tablet of MMH-522 4 times a day for 7 days. Three participants will be included in the dosing.
Group 2 (stage 2): Course administration, single dose - 2 tablets (sequential administration of tablets without interruption is allowed) of MMH-522 4 times a day for 7 days. Three participants will be included in the dosing.
Group 3 (stage 3): Course administration, single dose - 3 tablets (sequential administration of tablets without interruption is allowed) of MMH-522 4 times a day for 7 days. Three participants will be included in the dosing.
Group 4 (stage 4): Maximum tolerated dosage regimen of MMH-522 for 7 days. Three participants will be included in the dosing. Receives: Drug: MMH-522 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs) with toxicity grade 3 or higher
To evaluate the number of adverse events with toxicity grade 3 or higher (Common Terminology Criteria for Adverse Events (CTCAE) 5.0) during the therapy period. Based on medical records.
Measured: 7 days
Secondary outcomes (17)
Number of adverse events (AEs)
To evaluate the presence and nature of AEs during the therapy period. Based on medical records.
Measured: 7 days
Intensity (severity) of adverse events (AEs)
To evaluate the severity of AEs during the therapy period. Based on medical records.
Measured: 7 days
Causal relationship of adverse events (AEs) to the sudy drug
To evaluate the relationship of AEs to the sudy drug during the therapy period. Based on medical records.
Measured: 7 days
Outcome of adverse events (AEs)
To evaluate the outcome of AEs during the therapy period. Based on medical records.
Measured: 7 days
Number of serious adverse events (SAEs)
To evaluate the presence and nature of SAEs during the therapy period. Based on medical records.
Measured: 7 days
Intensity (severity) of serious adverse events (SAEs)
To evaluate the severity of SAEs during the therapy period. Based on medical records.
Measured: 7 days
Causal relationship of serious adverse events (SAEs) to the sudy drug
To evaluate the relationship of SAEs to the sudy drug during the therapy period. Based on medical records.
Measured: 7 days
Outcome of serious adverse events (SAEs
To evaluate the outcome of SAEs during the therapy period. Based on medical records.
Measured: 7 days
Number of participants with local changes in the oral mucosa (tolerability)
The presence and nature of subjective sensations and local changes in the oral mucosa (tolerability) during therapy with the study drug. Based on medical records.
Measured: 7 days
Changes in vital signs (blood pressure)
Dynamics of blood pressure during treatment with the study drug. Blood pressure measured in mm Hg. Based on medical records.
Measured: 7 days
Changes in vital signs (heart rate)
Dynamics of heart rate during treatment with the study drug. Pulse rate measured in beats per minute. Based on medical records.
Measured: 7 days
Changes in vital signs (oxygen saturation)
Dynamics of oxygen saturation during treatment with the study drug. Blood oxygen saturation is measured using a pulse oximeter and is expressed as a percentage. Based on medical records.
Measured: 7 days
Changes in vital signs (body temperature)
Dynamics of body temperature during treatment with the study drug. Temperature is measured in the armpit using a classic mercury-free thermometer. Based on medical records.
Measured: 7 days
Proportion of participants with clinically significant laboratory abnormalities
Measure is based on the hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values. Based on medical records.
Measured: After 24 hours and 7 days of study drug therapy
Frequency of clinically significant abnormalities
Frequency of clinically significant abnormalities in laboratory parameters after 24 hours and 7 days of therapy with the study drug.
Measured: After 24 hours and 7 days of study drug therapy
Proportion of participants with clinically significant electrocardiogram abnormalities
Proportion of participants with clinically significant electrocardiogram abnormalities after 1 hour, 24 hours, and 7 days of study drug therapy. Based on medical records.
Measured: After 1 hour, 24 hours, and 7 days of study drug therapy
Frequency of clinically significant deviations in electrocardiogram parameters
Frequency of clinically significant deviations in electrocardiogram parameters after 1 hour, 24 hours and 7 days of therapy with the study drug.
Measured: After 1 hour, 24 hours, and 7 days of study drug therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start12 Feb 2026
- Primary completion16 Apr 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-comparative, non-randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754279
- Sponsor's protocol ID
- MMH-522-001
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-comparative, Non-randomized Clinical Trial of the Safety and Tolerability of MMH-522 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07754279
- Acronym / sponsor ID
- MMH-522-001
- Conditions
- Cough
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 10 Aug 2026 (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.
Open-label, non-comparative, non-randomized clinical trial of the safety and tolerability of the drug MMH-450 in healthy volunteers consisting of 4 consecutive stages
Detailed description
Screening (Days -7-0, Visit 0) After signing a patient information sheet (PIS) and an informed consent form (ICF), the participant undergoes a screening examination on an outpatient basis (Days -7-0): medical history collection, physical examination (height, weight, vital signs: blood pressure, heart rate, body temperature, saturation)), pregnancy test, 12-lead ECG, breath alcohol test, laboratory tests (express urine analysis for drugs and medications, general blood and urine tests, blood chemistry, coagulation test, platelet aggregation test, HIV test, RPR test, HBsAg, HCV), determination of compliance with the inclusion/non-inclusion criteria. If the participant meets the inclusion criteria/does not meet the non-inclusion criteria, he or she is included in the study. The screening period lasts no more than 7 days.
Hospital admission (Day 1, Visit 1.1-1.3) A participant who has passed screening, meets the inclusion criteria, and does not meet the non-inclusion criteria will be admitted to the hospital on Day 1. Admission will take place from 8:00 to 9:00, admission to the hospital on the evening before is allowed (at the discretion of the test facility staff and with the consent of the participant). During hospital admission, the trial participant undergoes an objective examination prior to administration of the study drug, including measuring body weight, vital signs, a breath alcohol test, a 12-lead ECG, a urine express analysis for drugs and medications, a pregnancy test, and blood sampling for the development of methods for detecting the active components of the MMH-522 drug.
The first dose of MMH-522 is administered in the hospital under the supervision of medical staff at 10:00 (±20 min) on Day 1. The investigator assesses local tolerability of the drug immediately after administration and 15 minutes after administration of the study drug (SD), assesses subjective sensations after administration of the SD. In case of gagging or spitting out the drug, the participant repeats the attempt to take the test drug. A total of up to 3 attempts are allowed. Failure to take the drug will be recorded in the primary documents, and the participant will be excluded from the study and replaced by another participant (a replacement participant).
One hour after the first administration of the study drug, the investigator repeats the objective examination, measures vital signs, performs a 12-lead ECG, and assesses the safety of the test therapy (record any possible AEs).
The 2nd, 3rd and 4th doses of the study drug on Day 1 will be administered at 14:00 (±20 min), 18:00 (±20 min) and 22:00 (±20 min), respectively. The investigator will assess local tolerability of the drug immediately after administration and 15 minutes after each administration of the SD, assess subjective sensations after administration of the SD.
Within 24 hours of administering the first dose of the study drug, the participant is monitored by medical staff; the investigator assesses the safety of the study therapy (records possible AEs).
At 24 hours (±30 min) after administration of the first dose of the study drug, a repeat examination is performed, including a physical examination with assessment of vital signs, 12-lead ECG, laboratory tests (complete blood count and urine analysis, blood biochemistry, coagulation tests, platelet aggregation test), blood sampling for the development of methods for detecting the active components of MMH-522. The investigator assesses the safety of the study therapy (records possible AEs). The duration of hospital stay for conducting the research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), and the duration of the visit on Day 8 will be no more than 3 hours. Participants will receive the same menu during their stay in the hospital.
Drug administration period (Days 2-7) At 8:00 am (±20 min) on Day 2, the study drug is administered under the supervision of medical staff. The investigator assesses local tolerability of the drug immediately after administration and 15 minutes after administration of the SD. Starting with the daytime administration of the study drug on Day 2 and up to and including Day 7, the participant independently takes the drug 4 times a day, approximately at equal intervals in the morning (8:00-9:00 am), afternoon (12:00-1:00 and 16:00-17:00), and evening (20:00-21:00), indicating the exact time of administration of the study drug in the electronic participant diary (EPD), and recording any deterioration of their condition in the EPD; the physician monitors completion of the diary. The participant takes the study drug for a total of 7 days.
Final visit (Day 8, Visit 2) On Day 8, the hospital visit is scheduled for approximately 8:00 to 9:00. The participant visits the hospital fasting, and the investigator performs a physical examination, oral cavity examination, assesses subjective sensations after administration of the SD, measures vital signs, performs a breath alcohol test, 12-lead ECG, and laboratory tests (express urine analysis for drugs and medications, general blood and urine tests, blood chemistry, coagulation test, platelet aggregation test), blood sampling for developing methods for detecting active components of MMH-522; assesses compliance. The investigator assesses the safety of the study therapy (records possible AEs). If necessary, participants may be supervised after completion of all research procedures on Day 8 for up to 1 hour.
Unscheduled visit It is conducted in the event of an AE. The study participant is invited to visit the medical center. The investigator collects complaints, performs a physical examination, oral cavity examination, assesses subjective sensations after administration of the SD, measures vital signs. During the visit, the investigator decides on the further tactics regarding continued participation in the study and the need to prescribe AE therapy on an outpatient or inpatient basis. The participant may enter data on the AE that has occurred in the EPD or report it to the physician.
Early termination visit A participant who meets at least one withdrawal criterion is considered to have terminated their participation in the trial early. During the visit, the final visit procedures are performed, including an objective examination, measurement of vital signs, a breath alcohol test, 12-lead ECG, laboratory tests (express urine test for drugs and medications, general clinical blood and urine tests, blood chemistry test, coagulation test, platelet aggregation test), blood sampling for the development of methods for detecting the active components of MMH-522. The investigator indicates the date of termination of participation in the primary documentation and CRF, the date of the last administration of the study drug, notes the fact of early termination of participation in the study, the day of the participant's early exclusion from the study, the reason, and information about the return of the drug.
Monitoring of MMH-522 administration outside of the participants' stay in the hospital All participants will receive a reminder to take the study drug daily (Days 2-7) four times a day at 7:50, 11:50, 15:50, and 19:50. If a participant does not enter information about taking the SD into the EPD before the established periods, the participant and the investigator will receive a repeat reminder.
After each dose of MMH-522, the participant records the exact time of administration in the EPD. The investigator monitors the administration of MMH-522 by analyzing the records in the EPD. If there is no record of MMH-522 administration, the investigator contacts the participant to clarify the reason for not taking the study drug and, if the participant continues to participate in the trial, reminds them of the need to take MMH-522.
Stages of the trial The trial will be conducted in four stages. The stages will be carried out sequentially. Each subsequent stage will begin after the completion of the previous one and the conclusion of the Independent Committee for Monitoring Safety and Patient Data (ICMSPD ) on the safety and tolerability of the course administration at stages 1-4; upon completion of stage 4, a report on the phase I trial will be prepared.
The criteria for transition to the next stage are as follows:
Absence of severe AEs (grade 3 and above, CTCAE 5.0, Appendix 1) related to the cardiovascular system, gastrointestinal tract, skin and subcutaneous adipose tissue, laboratory abnormalities (in clinical and biochemical blood tests) associated with the administration of the study drug, severe life-threatening allergic reactions (generalized urticaria, angioedema, anaphylaxis) requiring intensive care.
In the event of one severe grade AE at each stage (grade 3 and above, CTCAE 5.0) related to the study drug, and AEs related to the study drug that led to the participant's early withdrawal from the study, as well as when new data appear indicating any changes in the benefit-risk ratio, an unscheduled meeting of the ICMSPD is held and a decision is made on the further tactics for conducting/completing the trial. If a decision is made to continue the trial, the current stage is repeated with three more participants.
Participants are screened separately before each stage. Stage 1 Course administration, single dose: 1 tablet of MMH-522 4 times a day for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing.
Stage 2 Course administration, single dose: 2 tablets of MMH-522 (consecutive administration of tablets without interruption is allowed) 4 times a day for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing.
Stage 3 Course administration, single dose: 3 tablets of MMH-522 (consecutive administration of tablets without interruption is allowed) 4 times a day for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing.
Stage 4 Repeat study of the maximum tolerated dosage regimen of MMH-522 for 7 days. The duration of hospital stay for conducting research procedures will be no more than 28 hours on Days 1-2 (approximately from 8:00 on Day 1 to 12:00 on Day 2), the duration of the visit on Day 8 will be no more than 3 hours. Three participants will be included in the dosing at stage 4.
For each stage, replacement participants who have successfully completed the screening procedures will be invited along with the main participants. If one of the participants is unable to be admitted to the hospital and participate in the trial for any reason, the replacement participant becomes a full participant in the study and undergoes all procedures according to the protocol. If all planned participants of the relevant stage are admitted to the hospital and receive the first dose of the study drug, the replacement participant will be excluded from the study.
Blood sampling for the development of methods for detecting the active components of MMH-522 will be performed three times on an empty stomach: 1) on Day 1 before administering the first dose of the study drug, 2) 24 hours (±30 min) after the start of administering the study drug, 3) 7 days after therapy with the study drug.
Then, blood serum is frozen for subsequent storage and transportation at -200С to the laboratory of the clinical trial Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-comparative, non-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| MMH-522 | Experimental | Drug: MMH-522The trial will be conducted in four stages. The stages will be carried out sequentially. Group 1 (stage 1): Course administration, single dose - 1 tablet of MMH-522 4 times a day for 7 days. Three participants will be included in the dosing. Group 2 (stage 2): Course administration, single dose - 2 tablets (sequential administration of tablets without interruption is allowed) of MMH-522 4 times a day for 7 days. Three participants will be included in the dosing. Group 3 (stage 3): Course administration, single dose - 3 tablets (sequential administration of tablets without interruption is allowed) of MMH-522 4 times a day for 7 days. Three participants will be included in the dosing. Group 4 (stage 4): Maximum tolerated dosage regimen of MMH-522 for 7 days. Three participants will be included in the dosing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females aged 18 to 45 years.
- A diagnosis of "healthy" was established by the examining physician based on a medical assessment , including medical history, vital signs, an objective examination, a 12-lead electrocardiogram, and laboratory test results.
- The body mass index ranges from 18.5 to 30 kg/m2 with a body weight over 50 kg.
- Availability of a participant information sheet and informed consent form for participation in the clinical trial, signed by the participant.
- Participants who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).
Key exclusion criteria (17 listed)
- A history of significant diseases, in the investigator's opinion, that may interfere with achieving the study's objectives: renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases.
- Any condition that may affect the absorption of the drug in the oral cavity or gastrointestinal tract (e.g., gastric resection or other gastrointestinal surgery other than appendectomy).
- Hypersensitivity to any component of the drug used in treatment; a history of anaphylactic reactions to drugs or general allergic reactions that, in the opinion of the investigator, may affect the outcome of the study.
- Abnormalities in laboratory blood and urine tests (general clinical, biochemical, coagulogram, platelet aggregation parameters).
- Abnormal in vital signs parameters: systolic blood pressure <90 mmHg or >139 mmHg; diastolic blood pressure <60 mmHg or >89 mmHg; heart rate <50 bpm or >99 bpm, body temperature >37.0, saturation <95%.
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 |
|---|---|---|
| MMH-522Per os, without food (at least 30 minutes before or after meals and any liquid). The tablet is kept in the mouth until completely dissolved. Duration of therapy - 7 days | Drug | MMH-522 |
Primary outcome
Number of adverse events (AEs) with toxicity grade 3 or higher
Time frame: 7 days
To evaluate the number of adverse events with toxicity grade 3 or higher (Common Terminology Criteria for Adverse Events (CTCAE) 5.0) during the therapy period. Based on medical records.
17 secondary outcomes
Number of adverse events (AEs)
Time frame: 7 days
Intensity (severity) of adverse events (AEs)
Time frame: 7 days
Causal relationship of adverse events (AEs) to the sudy drug
Time frame: 7 days
Outcome of adverse events (AEs)
Time frame: 7 days
Number of serious adverse events (SAEs)
Time frame: 7 days
Intensity (severity) of serious adverse events (SAEs)
Time frame: 7 days
Causal relationship of serious adverse events (SAEs) to the sudy drug
Time frame: 7 days
Outcome of serious adverse events (SAEs
Time frame: 7 days
Number of participants with local changes in the oral mucosa (tolerability)
Time frame: 7 days
Changes in vital signs (blood pressure)
Time frame: 7 days
Changes in vital signs (heart rate)
Time frame: 7 days
Changes in vital signs (oxygen saturation)
Time frame: 7 days
Changes in vital signs (body temperature)
Time frame: 7 days
Proportion of participants with clinically significant laboratory abnormalities
Time frame: After 24 hours and 7 days of study drug therapy
Frequency of clinically significant abnormalities
Time frame: After 24 hours and 7 days of study drug therapy
Proportion of participants with clinically significant electrocardiogram abnormalities
Time frame: After 1 hour, 24 hours, and 7 days of study drug therapy
Frequency of clinically significant deviations in electrocardiogram parameters
Time frame: After 1 hour, 24 hours, and 7 days of study drug therapy
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 10 Sep 2026.
Related trials for Cough
RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Recruiting
Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
Head and Neck Cancers
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 MMH-522 in people with Cough, run by Materia Medica Holding 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 5 inclusion and 17 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 10 Sep 2026. 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?
Number of adverse events (AEs) with toxicity grade 3 or higher (time frame: 7 days). 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 Sep 2026.