New sleep tablet MMH-450 enters first human safety trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females aged 18 to 45 years. 2. 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. 3. 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. 4. Body mass index between 18.5 and 30 kg/m2 with a body weight over 50 kg. 5. Availability of a participant information sheet and an informed consent form for participation in the clinical trial signed by the participant. 6. Participants who have agreed to use a reliable method of contraception during the trial (for men and women of reproductive potential). Exclusion Criteria: 1. 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. 2. 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). 3. 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. 4. Abnormalities in laboratory blood and urine tests. 5. 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%. 6. 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. 7. Donor blood donation (450 ml of blood or more) less than 3 months before the start of the study. 8. Participation in other clinical trials within 3 months prior to inclusion in the study. 9. 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. 10. Positive breath alcohol test. 11. Smoking cigarettes, cigars, electronic cigarettes, or vaping within 3 months prior to taking the study drug. 12. Positive urine rapid test for narcotic and medicinal substances (amphetamine, barbiturates, benzodiazepine, cocaine, marijuana, methadone, methamphetamine, morphine, MDMA (ecstasy), tricyclic antidepressants). 13. Positive test results for hepatitis B, C, HIV infection or syphilis. 14. Unwillingness or inability to comply with lifestyle recommendations and restrictions prescribed by this protocol. 15. Participants who, in the opinion of the investigator, will not comply with the study drug administration schedule. 16. Pregnancy, breastfeeding, childbirth less than 3 months before inclusion in the study. 17. 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. 18. 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. 19. The participant failed the screening procedure. 20. The occurrence of an adverse event requiring discontinuation of the study drug. 21. Erroneous inclusion of an ineligible participant in the study. 22. The participant's desire to terminate the study early for any reason. 23. The participant's inclusion in another clinical trial. 24. 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.