Clinical Trial of the Safety and Tolerability of MMH-522 in Healthy Volunteers

NCT07754279 | Completed Phase 1 DMC

• 1 other identifier: MMH-522-001
• Study Type: interventional
• Target: 16
• 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 consisting of 4 consecutive stages

Conditions

Cough

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (17)

• 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-522

EXPERIMENTAL

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. 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. 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. Stage 4: Maximum tolerated dosage regimen of MMH-522 for 7 days. Three participants will be included in the dosing.

Drug: MMH-522

Interventions

MMH-522 DRUG

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

MMH-522

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" 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).

You may not qualify if:

• 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.
• 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, 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.

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

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: August 4, 2026
• First Posted: August 10, 2026
• Study Start: February 12, 2026
• Primary Completion: April 16, 2026
• Study Completion: May 7, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

RU (1)