Open-label, Non-comparative, Non-randomized Clinical Trial of the Safety and Tolerability of MMH-522 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs) with toxicity grade 3 or higher
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 consisting of 4 consecutive stages
详细描述
Screening (Days -7-0, Visit 0) After signing a patient information sheet (PIS) and an informed consent form (ICF), the participant undergoes a screening examination on an outpatient basis (Days -7-0): medical history collection, physical examination (height, weight, vital signs: blood pressure, heart rate, body temperature, saturation)), pregnancy test, 12-lead ECG, breath alcohol test, laboratory tests (express urine analysis for drugs and medications, general blood and urine tests, blood chemistry, coagulation test, platelet aggregation test, HIV test, RPR test, HBsAg, HCV), determination of compliance with the inclusion/non-inclusion criteria. If the participant meets the inclusion criteria/does not meet the non-inclusion criteria, he or she is included in the study. The screening period lasts no more than 7 days.
Hospital admission (Day 1, Visit 1.1-1.3) A participant who has passed screening, meets the inclusion criteria, and does not meet the non-inclusion criteria will be admitted to the hospital on Day 1. Admission will take place from 8:00 to 9:00, admission to the hospital on the evening before is allowed (at the discretion of the test facility staff and with the consent of the participant). During hospital admission, the trial participant undergoes an objective examination prior to administration of the study drug, including measuring body weight, vital signs, a breath alcohol test, a 12-lead ECG, a urine express analysis for drugs and medications, a pregnancy test, and blood sampling for the development of methods for detecting the active components of the MMH-522 drug.
The first dose of MMH-522 is administered in the hospital under the supervision of medical staff at 10:00 (±20 min) on Day 1. The investigator assesses local tolerability of the drug immediately after administration and 15 minutes after administration of the study drug (SD), assesses subjective sensations after administration of the SD. In case of gagging or spitting out the drug, the participant repeats the attempt to take the test drug. A total of up to 3 attempts are allowed. Failure to take the drug will be recorded in the primary documents, and the participant will be excluded from the study and replaced by another participant (a replacement participant).
One hour after the first administration of the study drug, the investigator repeats the objective examination, measures vital signs, performs a 12-lead ECG, and assesses the safety of the test therapy (record any possible AEs).
The 2nd, 3rd and 4th doses of the study drug on Day 1 will be administered at 14:00 (±20 min), 18:00 (±20 min) and 22:00 (±20 min), respectively. The investigator will assess local tolerability of the drug immediately after administration and 15 minutes after each administration of the SD, assess subjective sensations after administration of the SD.
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" 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).
排除标准
- •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.
研究组 & 干预措施
MMH-522
The trial will be conducted in four stages. The stages will be carried out sequentially.
Group 1 (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.
Group 2 (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.
Group 3 (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.
Group 4 (stage 4): Maximum tolerated dosage regimen of MMH-522 for 7 days. Three participants will be included in the dosing.
干预措施: MMH-522 (Drug)
结局指标
主要结局
Number of adverse events (AEs) with toxicity grade 3 or higher
时间窗: 7 days
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.
次要结局
- Intensity (severity) of adverse events (AEs)(7 days)
- Number of adverse events (AEs)(7 days)
- Outcome of serious adverse events (SAEs(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)
- 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 24 hours and 7 days of study drug therapy)
- Frequency of clinically significant abnormalities(After 24 hours and 7 days of study drug therapy)
- Proportion of participants with clinically significant electrocardiogram abnormalities(After 1 hour, 24 hours, and 7 days of study drug therapy)
- Frequency of clinically significant deviations in electrocardiogram parameters(After 1 hour, 24 hours, and 7 days of study drug therapy)