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

Completed · Phase 1

Conditions studied: Cough

In brief

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

Key facts

Study ID

NCT07754279

Run by

Materia Medica Holding

People needed

16

Starts

2026-02-12

Expected to finish

2026-05-07

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.
• 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, 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.
• The participant is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or an appointed official responsible for the conduct of the study, or their immediate family member.

Where it is running

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

Full record on ClinicalTrials.gov

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