Sleep DisordersPhase 1NCT07708623
Clinical Trial of the Safety and Tolerability of the Drug MMH-450 in Healthy Volunteers
A Phase 1 study testing MMH-450 in people with Sleep Disorders, 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- MMH-450
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteRussia
- Study dates
- 15 Aug 2025to 10 Dec 2025
- 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" as determined by the study physician based on a medical assessment, including medical history, vital signs, physical examination, 12-lead electrocardiogram, and laboratory test results.
- Participants with physiological sleep and an average daily routine (alternating 8 hours of work, 8 hours of rest (active) and 6-8 hours of sleep), with a habitual bedtime between 9:00 p.m. and 11:00 p.m.
- Body mass index between 18.5 and 30 kg/m2 with a body weight over 50 kg.
- Availability of a participant information sheet and an informed consent form for participation in the clinical trial signed by the participant.
- Participants who have agreed to use a reliable method of contraception during the trial (for men and women of reproductive potential).
Who cannot join
- The presence in the anamnesis of data on diseases that are significant, in the opinion of the investigator, which may interfere with achieving the purpose of the study: 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 surgical intervention for gastrointestinal diseases, except 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 investigator's opinion, may affect the outcome of the study.
- Abnormalities in laboratory blood and urine tests.
- Abnormalities in vital signs: 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 > 100 bpm, mean corrected PR < 100 or > 220 ms, PQ < 120 or > 200 ms, ST > 320 ms, QT (QTcF) > 450 ms, QRS > 120 ms, HR < 50 or > 99 bpm. Abnormal PQRST patterns.
Show all 24Show 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, electronic cigarettes, or vaping within 3 months prior to taking the study drug.
- Positive urine rapid test for narcotic and medicinal substances (amphetamine, barbiturates, benzodiazepine, cocaine, marijuana, methadone, methamphetamine, morphine, MDMA (ecstasy), tricyclic antidepressants).
- Positive test results for hepatitis B, C, HIV infection or syphilis.
- Unwillingness or inability to comply with lifestyle recommendations and restrictions prescribed by this protocol.
- Participants who, in the opinion of the investigator, will not comply with the study drug administration schedule.
- Pregnancy, breastfeeding, childbirth less than 3 months before inclusion in the study.
- A participant is a member of the center's research staff directly involved in the study and is an immediate family member of the investigator. "Immediate family members" are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted.
- The participant works for the company NPF MATERIA MEDICA HOLDING LLC, i.e. is an employee of the company, a temporary contract worker, or an appointed official responsible for the implementation of the study, or their immediate family member.
- The participant failed the screening procedure.
- The occurrence of an adverse event requiring discontinuation of the study drug.
- Erroneous inclusion of an ineligible participant in the study.
- The participant's desire to terminate the study early for any reason.
- The participant's inclusion in another clinical trial.
- Cases not specified in the protocol, when the investigator believes that the participant's continued participation in the study would be detrimental to the participant.
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 the Drug MMH-450 in Healthy Volunteers
Open-label, non-comparative, non-randomized clinical trial of the safety and tolerability of the drug MMH-450 in healthy volunteers
Read the detailed description
Design: open-label, non-comparative, non-randomized clinical trial consisting of 4 consecutive stages.
The study will include healthy volunteers (hereinafter referred to as 'participants') of both sexes aged 18 to 45 years who meet the inclusion criteria and do not meet the exclusion criteria.
Screening (Days -7-0, Visit 0). After signing the participant information sheet and informed consent form (ICF), the study participant undergoes a screening examination on an outpatient basis (Days -7-0): medical history collection, physical examination (height, weight, vital signs, pregnancy test, 12-lead ECG, breath alcohol test, laboratory tests (rapid urine test for drugs and medications, general clinical blood and urine tests, blood chemistry, HIV test, RPR test, HBsAg, HCV), determination of compliance with inclusion/exclusion criteria. If the inclusion criteria are met/there are no exclusion criteria, the participant is included in the study. The screening period lasts no more than 7 days.
Hospital admission (Day 1, Visit 1.1-1.3). Participants who pass the screening, meet the inclusion criteria, and do not meet the exclusion criteria are admitted to the hospital on Day 1. Admission will take place from 8:00 a.m. to 1:00 p.m. (at least 8 hours before the first dose of MMH-450). During hospital admission, the study participant undergoes an objective examination prior to administration of the study drug, including measurement of body weight, vital signs, a breath alcohol test, 12-lead ECG, rapid urine test for drugs and medications, pregnancy test, blood sampling for the development of methods for detecting the active components of MMH-450, completion of the Karolinska Sleepiness Scale together with a doctor, Epworth Sleepiness Scale, TMT test (Trail Making Test).
The first dose of the study drug will be administered in the hospital under the supervision of medical staff in the evening, approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) on Day 1. The doctor will assess the local tolerability of the drug. In case of gagging or spitting out the drug, the participant will repeat the attempt to take the study drug. A total of up to 3 attempts are allowed. Failure to take the drug will be recorded in the source documents, and the participant will be excluded from the study and replaced by another participant (a substitute participant).
One hour after taking the study drug, the doctor will repeat the objective examination, assess vital signs, perform a 12-lead ECG, and evaluate the safety of the study therapy (record any possible AEs).
Twelve hours after taking the drug, a repeat examination will be performed, including an objective examination with an assessment of vital signs, laboratory tests (general clinical blood and urine tests, biochemical blood analysis), and blood sampling to develop methods for determining the active components of study drug. The Karolinska Sleepiness Scale and TMT test are completed. The doctor assesses the safety of the study therapy (records any possible AEs). For self-administration, the participant will be given the study drug and instructions for its use. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on day 1 to 12:00 p.m. on day 2). Participants will receive the same menu during their stay in the hospital.
The study will use an electronic participant diary (EPD). On Day 1, the doctor will provide instructions on how to use the EPD. In the EPD, the participant will record any possible deterioration in their condition on a daily basis (Days 1-8), complete the Karolinska Sleepiness Scale at baseline, before taking the first dose of the study drug, 12 hours after taking it, then daily while taking the study drug (Days 2-7), and at the final visit (Day 8).
Drug administration period (Days 2-7). On Days 2-7, the participant independently takes the study drug approximately 1 hour before bedtime (at 21:00 ±10 minutes) daily, indicating the exact time of taking the study drug in the EPD, completes the Karolinska Sleepiness Scale in the EPD (on Day 2, the scale is completed twice: the first time is 12 hours after taking the first dose of the study drug during hospitalization on Day 1, and the second time is in the evening on an outpatient basis on Day 2), enters data on AEs into the EPD; the doctor monitors the completion of the diary.
Final visit (Day 8, Visit 2). On Day 8, the hospital visit is scheduled for approximately 8:00 a.m. to 1:00 p.m. The participant visits the hospital on an empty stomach, where the doctor conducts an objective examination, measures vital signs, performs a breath alcohol test, 12-lead ECG, laboratory tests (rapid urine test for drugs and medications, general clinical blood and urine tests, blood chemistry test), blood sampling to develop methods for detecting the active components of the study drug; assesses compliance; the participant, together with the doctor, completes the Karolinska Sleepiness Scale (in the EPD), the Epworth Sleepiness Scale, and the TMT test. The doctor assesses the safety of the study therapy (records possible AEs). After completing all trial procedures on Day 8, participants will be monitored for up to 1 hour, if necessary.
Unscheduled visit. It is conducted in the event of an AE. The study participant is invited to visit the medical center. The doctor collects complaints, conducts an objective examination, and measures vital signs. During the visit, the doctor decides on further tactics regarding continued participation in the trial 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 doctor.
Early termination visit. A participant who meets at least one exclusion criterion is considered to have terminated their participation in the trial early. During the visit, final visit procedures are performed, including an objective examination, measurement of vital signs, a breath alcohol test, 12-lead ECG, laboratory tests (rapid urine test for drugs and medications, general clinical blood and urine tests, blood chemistry test), blood sampling for the development of methods for detecting the active components of the study drug; the participant, together with the doctor, completes the Karolinska Sleepiness Scale, the Epworth Sleepiness Scale, and the TMT test. In the source documents and Case Report Form, the doctor indicates the date of completion of participation, 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 the study drug administration outside of the participants' stay in the hospital All participants will receive a reminder to take the study drug at 8:30 p.m. If the participant does not enter information about taking the study drug in the EPD by 9:30 p.m., the participant and the investigator will receive a repeat reminder.
After each dose of the study drug, the participant notes the exact time of administration in the EPD. The doctor monitors the administration of study drug by analyzing the records in the EPD. If there is no record of the study drug administration, the doctor contacts the participant to clarify the reason for not taking the study drug and, if the participant continues to participate in the study, reminds them of the need to take the study drug.
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 receipt of the conclusion of the Independent Committee for Monitoring Safety and Patient Data (ICMSPD ) on the safety and tolerability of the course administration in 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) 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 severe grade 1 AEs (grade 3 and above, CTCAE 5.0) associated with the study drug and AEs associated with 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 study. If a decision is made to continue the study, the current stage is repeated with 3 more participants.
Participants are screened separately before each stage. Stage 1 Course administration, single dose: 1 tablet of MMH-450 once in the evening, approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the dosage.
Stage 2 Course administration, single dose: 2 tablets of MMH-450 once in the evening, approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the dosage.
Stage 3 Course administration, single dose: 4 tablets of MMH-450 once in the evening, approximately 1 hour before bedtime (at 21:00 ±10 minutes), for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the dosage.
Stage 4 Repeat study of the maximum tolerated dosage regimen of MMH-450 approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the stage 4 of the study.
For each stage, 1 replacement participant who has successfully passed the screening procedures will be invited along with the 3 participants. If one of the participants is unable to be admitted to the hospital and participate in the study 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 at the relevant stage are admitted to the hospital and receive the study drug, the replacement participant will be excluded from the study.
Blood sampling for the development of methods for determining the active components of the study drug is performed three times: 1) on Day 1 before taking the first dose of the study drug, 2) 12 hours after taking the first dose of the study drug, 3) 7 days after therapy with the study drug. The blood serum is then frozen and transported and stored at - 200С in the clinical trial Sponsor's laboratory.
- Conditions
- Sleep Disorders
- Being tested
- MMH-450
- Keywords
- healthy volunteers
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-450Drug
Duration of therapy - 7 days. Per os, without food. The tablet is kept in the mouth until completely dissolved.
| Study group | Role | What they receive |
|---|---|---|
| MMH-450 | Experimental | Per os without food. The tablet should be kept in mouth until completely dissolved. Receives: Drug: MMH-450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs) with grade 3 or higher toxicity
To evaluate the number of adverse events with grade 3 or higher toxicity (Common Terminology Criteria for Adverse Events (CTCAE)) during the therapy period. Based on medical records.
Measured: 7 days
Secondary outcomes (20)
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 12 hours and 7 days of study drug therapy
Frequency of clinically significant abnormalities
Frequency of clinically significant abnormalities in laboratory parameters after 12 hours and 7 days of therapy with the study drug.
Measured: After 12 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, 12 hours, and 7 days of study drug therapy. Based on medical records.
Measured: After 1 hour, 12 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, 12 hours and 7 days of therapy with the study drug.
Measured: After 1 hour, 12 hours, and 7 days of study drug therapy
Change in mean Karolinska Sleepiness Scale score
Change in mean Karolinska Sleepiness Scale score during 7 days of treatment with study drug.
- extremely alert
- very alert
- alert
- rather alert
- neither alert nor sleepy
- some signs of sleepiness
- sleepy, but no effort to keep awake
- sleepy, some effort to keep awake
- very sleepy, great effort to keep awake, fighting sleep.
Measured: 7 days
Change in mean Epworth Sleepiness Scale score
Change in mean Epworth Sleepiness Scale score after 7 days of treatment with study drug.
The Epworth sleepiness scale results range from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness. A result under 10 may not be cause for concern or it could identify you have trouble sleeping (insomnia). A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness. The results are as follows: 0 to 5: Low daytime sleepiness (normal); 6 to 10: High daytime sleepiness (normal); 11 to 12: Mild excessive daytime sleepiness; 13 to 15: Moderate excessive daytime sleepiness; 16 to 24: Severe excessive daytime sleepiness.
Measured: 7 days
Change in mean time to complete the trail-finding test
Change in mean time to complete the trail-finding test after 7 days of treatment with study drug. The generally accepted average completion times are:TMT-A: Normal performance is typically 25 to 35 seconds (the average test execution time is 29 seconds). Scores greater than 78 seconds generally indicate impairment.TMT-B: Normal performance is typically 60 to 75 seconds. Scores greater than 273 seconds generally indicate impairment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start15 Aug 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies 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
- 18 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
- NCT07708623
- Sponsor's protocol ID
- MMH-450-001
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 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 the Drug MMH-450 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07708623
- Acronym / sponsor ID
- MMH-450-001
- Conditions
- Sleep Disorders
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 16 Jul 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
Detailed description
Design: open-label, non-comparative, non-randomized clinical trial consisting of 4 consecutive stages.
The study will include healthy volunteers (hereinafter referred to as 'participants') of both sexes aged 18 to 45 years who meet the inclusion criteria and do not meet the exclusion criteria.
Screening (Days -7-0, Visit 0). After signing the participant information sheet and informed consent form (ICF), the study participant undergoes a screening examination on an outpatient basis (Days -7-0): medical history collection, physical examination (height, weight, vital signs, pregnancy test, 12-lead ECG, breath alcohol test, laboratory tests (rapid urine test for drugs and medications, general clinical blood and urine tests, blood chemistry, HIV test, RPR test, HBsAg, HCV), determination of compliance with inclusion/exclusion criteria. If the inclusion criteria are met/there are no exclusion criteria, the participant is included in the study. The screening period lasts no more than 7 days.
Hospital admission (Day 1, Visit 1.1-1.3). Participants who pass the screening, meet the inclusion criteria, and do not meet the exclusion criteria are admitted to the hospital on Day 1. Admission will take place from 8:00 a.m. to 1:00 p.m. (at least 8 hours before the first dose of MMH-450). During hospital admission, the study participant undergoes an objective examination prior to administration of the study drug, including measurement of body weight, vital signs, a breath alcohol test, 12-lead ECG, rapid urine test for drugs and medications, pregnancy test, blood sampling for the development of methods for detecting the active components of MMH-450, completion of the Karolinska Sleepiness Scale together with a doctor, Epworth Sleepiness Scale, TMT test (Trail Making Test).
The first dose of the study drug will be administered in the hospital under the supervision of medical staff in the evening, approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) on Day 1. The doctor will assess the local tolerability of the drug. In case of gagging or spitting out the drug, the participant will repeat the attempt to take the study drug. A total of up to 3 attempts are allowed. Failure to take the drug will be recorded in the source documents, and the participant will be excluded from the study and replaced by another participant (a substitute participant).
One hour after taking the study drug, the doctor will repeat the objective examination, assess vital signs, perform a 12-lead ECG, and evaluate the safety of the study therapy (record any possible AEs).
Twelve hours after taking the drug, a repeat examination will be performed, including an objective examination with an assessment of vital signs, laboratory tests (general clinical blood and urine tests, biochemical blood analysis), and blood sampling to develop methods for determining the active components of study drug. The Karolinska Sleepiness Scale and TMT test are completed. The doctor assesses the safety of the study therapy (records any possible AEs). For self-administration, the participant will be given the study drug and instructions for its use. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on day 1 to 12:00 p.m. on day 2). Participants will receive the same menu during their stay in the hospital.
The study will use an electronic participant diary (EPD). On Day 1, the doctor will provide instructions on how to use the EPD. In the EPD, the participant will record any possible deterioration in their condition on a daily basis (Days 1-8), complete the Karolinska Sleepiness Scale at baseline, before taking the first dose of the study drug, 12 hours after taking it, then daily while taking the study drug (Days 2-7), and at the final visit (Day 8).
Drug administration period (Days 2-7). On Days 2-7, the participant independently takes the study drug approximately 1 hour before bedtime (at 21:00 ±10 minutes) daily, indicating the exact time of taking the study drug in the EPD, completes the Karolinska Sleepiness Scale in the EPD (on Day 2, the scale is completed twice: the first time is 12 hours after taking the first dose of the study drug during hospitalization on Day 1, and the second time is in the evening on an outpatient basis on Day 2), enters data on AEs into the EPD; the doctor monitors the completion of the diary.
Final visit (Day 8, Visit 2). On Day 8, the hospital visit is scheduled for approximately 8:00 a.m. to 1:00 p.m. The participant visits the hospital on an empty stomach, where the doctor conducts an objective examination, measures vital signs, performs a breath alcohol test, 12-lead ECG, laboratory tests (rapid urine test for drugs and medications, general clinical blood and urine tests, blood chemistry test), blood sampling to develop methods for detecting the active components of the study drug; assesses compliance; the participant, together with the doctor, completes the Karolinska Sleepiness Scale (in the EPD), the Epworth Sleepiness Scale, and the TMT test. The doctor assesses the safety of the study therapy (records possible AEs). After completing all trial procedures on Day 8, participants will be monitored for up to 1 hour, if necessary.
Unscheduled visit. It is conducted in the event of an AE. The study participant is invited to visit the medical center. The doctor collects complaints, conducts an objective examination, and measures vital signs. During the visit, the doctor decides on further tactics regarding continued participation in the trial 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 doctor.
Early termination visit. A participant who meets at least one exclusion criterion is considered to have terminated their participation in the trial early. During the visit, final visit procedures are performed, including an objective examination, measurement of vital signs, a breath alcohol test, 12-lead ECG, laboratory tests (rapid urine test for drugs and medications, general clinical blood and urine tests, blood chemistry test), blood sampling for the development of methods for detecting the active components of the study drug; the participant, together with the doctor, completes the Karolinska Sleepiness Scale, the Epworth Sleepiness Scale, and the TMT test. In the source documents and Case Report Form, the doctor indicates the date of completion of participation, 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 the study drug administration outside of the participants' stay in the hospital All participants will receive a reminder to take the study drug at 8:30 p.m. If the participant does not enter information about taking the study drug in the EPD by 9:30 p.m., the participant and the investigator will receive a repeat reminder.
After each dose of the study drug, the participant notes the exact time of administration in the EPD. The doctor monitors the administration of study drug by analyzing the records in the EPD. If there is no record of the study drug administration, the doctor contacts the participant to clarify the reason for not taking the study drug and, if the participant continues to participate in the study, reminds them of the need to take the study drug.
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 receipt of the conclusion of the Independent Committee for Monitoring Safety and Patient Data (ICMSPD ) on the safety and tolerability of the course administration in 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) 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 severe grade 1 AEs (grade 3 and above, CTCAE 5.0) associated with the study drug and AEs associated with 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 study. If a decision is made to continue the study, the current stage is repeated with 3 more participants.
Participants are screened separately before each stage. Stage 1 Course administration, single dose: 1 tablet of MMH-450 once in the evening, approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the dosage.
Stage 2 Course administration, single dose: 2 tablets of MMH-450 once in the evening, approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the dosage.
Stage 3 Course administration, single dose: 4 tablets of MMH-450 once in the evening, approximately 1 hour before bedtime (at 21:00 ±10 minutes), for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the dosage.
Stage 4 Repeat study of the maximum tolerated dosage regimen of MMH-450 approximately 1 hour before bedtime (at 9:00 p.m. ±10 minutes) for 7 days. The duration of hospitalization will be no more than 28 hours (approximately from 8:00 a.m. on Day 1 to 12:00 p.m. on Day 2). Three participants will be included in the stage 4 of the study.
For each stage, 1 replacement participant who has successfully passed the screening procedures will be invited along with the 3 participants. If one of the participants is unable to be admitted to the hospital and participate in the study 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 at the relevant stage are admitted to the hospital and receive the study drug, the replacement participant will be excluded from the study.
Blood sampling for the development of methods for determining the active components of the study drug is performed three times: 1) on Day 1 before taking the first dose of the study drug, 2) 12 hours after taking the first dose of the study drug, 3) 7 days after therapy with the study drug. The blood serum is then frozen and transported and stored at - 200С in the clinical trial Sponsor's laboratory.
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-450 | Experimental | Drug: MMH-450Per os without food. The tablet should be kept in mouth until completely dissolved. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females aged 18 to 45 years.
- A diagnosis of "healthy" as determined by the study physician based on a medical assessment, including medical history, vital signs, physical examination, 12-lead electrocardiogram, and laboratory test results.
- Participants with physiological sleep and an average daily routine (alternating 8 hours of work, 8 hours of rest (active) and 6-8 hours of sleep), with a habitual bedtime between 9:00 p.m. and 11:00 p.m.
- Body mass index between 18.5 and 30 kg/m2 with a body weight over 50 kg.
- Availability of a participant information sheet and an informed consent form for participation in the clinical trial signed by the participant.
Key exclusion criteria (24 listed)
- The presence in the anamnesis of data on diseases that are significant, in the opinion of the investigator, which may interfere with achieving the purpose of the study: 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 surgical intervention for gastrointestinal diseases, except 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 investigator's opinion, may affect the outcome of the study.
- Abnormalities in laboratory blood and urine tests.
- Abnormalities in vital signs: 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-450Duration of therapy - 7 days. Per os, without food. The tablet is kept in the mouth until completely dissolved. | Drug | MMH-450 |
Primary outcome
Number of adverse events (AEs) with grade 3 or higher toxicity
Time frame: 7 days
To evaluate the number of adverse events with grade 3 or higher toxicity (Common Terminology Criteria for Adverse Events (CTCAE)) during the therapy period. Based on medical records.
20 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 12 hours and 7 days of study drug therapy
Frequency of clinically significant abnormalities
Time frame: After 12 hours and 7 days of study drug therapy
Proportion of participants with clinically significant electrocardiogram abnormalities
Time frame: After 1 hour, 12 hours, and 7 days of study drug therapy
Frequency of clinically significant deviations in electrocardiogram parameters
Time frame: After 1 hour, 12 hours, and 7 days of study drug therapy
Change in mean Karolinska Sleepiness Scale score
Time frame: 7 days
Change in mean Epworth Sleepiness Scale score
Time frame: 7 days
Change in mean time to complete the trail-finding test
Time frame: 7 days
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 4 Aug 2026.
Related trials for Sleep Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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-450 in people with Sleep Disorders, 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 6 inclusion and 24 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 4 Aug 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 grade 3 or higher toxicity (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 4 Aug 2026.