Clinical Trial of the Safety and Tolerability of the Drug MMH-450 in Healthy Volunteers

NCT07708623 | Completed Phase 1

• 1 other identifier: MMH-450-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, non-comparative, non-randomized clinical trial of the safety and tolerability of the drug MMH-450 in healthy volunteers

Conditions

Sleep Disorders

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (20)

• Number of adverse events (AEs)

  7 days

• Intensity (severity) of adverse events (AEs)

  7 days

• Causal relationship of adverse events (AEs) to the sudy drug

  7 days

• Outcome of adverse events (AEs)

  7 days

• Number of serious adverse events (SAEs)

  7 days

Study Arms (1)

MMH-450

EXPERIMENTAL

Per os without food. The tablet should be kept in mouth until completely dissolved.

Drug: MMH-450

Interventions

MMH-450 DRUG

Duration of therapy - 7 days. Per os, without food. The tablet is kept in the mouth until completely dissolved.

MMH-450

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Donor blood donation (450 ml of blood or more) less than 3 months before the start of 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.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (1)

First Moscow State Medical University named after I.M. Sechenov/Center for Clinical Research of Drugs

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, non-comparative, non-randomized clinical trial

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: August 15, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: July 16, 2026

Record last verified: 2026-06

Locations

RU (1)