Open-label, Non-comparative, Non-randomized Clinical Trial of the Safety and Tolerability of the Drug MMH-450 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs) with grade 3 or higher toxicity
研究概览
简要总结
Open-label, non-comparative, non-randomized clinical trial of the safety and tolerability of the drug MMH-450 in healthy volunteers
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
- •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.
研究组 & 干预措施
MMH-450
Per os without food. The tablet should be kept in mouth until completely dissolved.
干预措施: MMH-450 (Drug)
结局指标
主要结局
Number of adverse events (AEs) with grade 3 or higher toxicity
时间窗: 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.
次要结局
- 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)
- Intensity (severity) of serious adverse events (SAEs)(7 days)
- Causal relationship of serious adverse events (SAEs) to the sudy drug(7 days)
- Outcome of serious adverse events (SAEs)(7 days)
- Number of participants with local changes in the oral mucosa (tolerability)(7 days)
- Changes in vital signs (blood pressure)(7 days)
- Changes in vital signs (heart rate)(7 days)
- Changes in vital signs (oxygen saturation)(7 days)
- Changes in vital signs (body temperature)(7 days)
- Proportion of participants with clinically significant laboratory abnormalities(After 12 hours and 7 days of study drug therapy)
- Frequency of clinically significant abnormalities(After 12 hours and 7 days of study drug therapy)
- Proportion of participants with clinically significant electrocardiogram abnormalities(After 1 hour, 12 hours, and 7 days of study drug therapy)
- Frequency of clinically significant deviations in electrocardiogram parameters(After 1 hour, 12 hours, and 7 days of study drug therapy)
- Change in mean Karolinska Sleepiness Scale score(7 days)
- Change in mean Epworth Sleepiness Scale score(7 days)
- Change in mean time to complete the trail-finding test(7 days)