A Phase 1 interventional study of MMH-522 in Cough, sponsored by Materia Medica Holding. Completed at 1 site in Russia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Materia Medica Holding · Phase 1, Interventional, and Treatment
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
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Materia Medica Holding is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: MMH-522
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
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.
Time frame: 7 days
Number of adverse events (AEs)
To evaluate the presence and nature of AEs during the therapy period. Based on medical records.
Time frame: 7 days
Intensity (severity) of adverse events (AEs)
To evaluate the severity of AEs during the therapy period. Based on medical records.
Time frame: 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.
Time frame: 7 days
Outcome of adverse events (AEs)
To evaluate the outcome of AEs during the therapy period. Based on medical records.
Time frame: 7 days
Number of serious adverse events (SAEs)
To evaluate the presence and nature of SAEs during the therapy period. Based on medical records.
Time frame: 7 days
Intensity (severity) of serious adverse events (SAEs)
To evaluate the severity of SAEs during the therapy period. Based on medical records.
Time frame: 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.
Time frame: 7 days
Outcome of serious adverse events (SAEs
To evaluate the outcome of SAEs during the therapy period. Based on medical records.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 1 hour, 24 hours, and 7 days of study drug therapy
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.