A Phase 1, Double-blind, Randomized, Placebo controlled study, to assess the Safety, tolerability and pharmacokinetics of single and multiple ascending dose of MKP 11093 suspension administered orally in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Single Ascending Dose (SAD)-To evaluate the safety and tolerability of the Different dose levels of MKP 11093 after single-dose administration
研究概览
简要总结
Primary Objective is to evaluate the safety and tolerability of the Different dose levels of MKP 11093 after single-dose administration and Secondary Objective is to characterize the single-dose pharmacokinetic profiles of MKP 11093 in human subjects and To evaluate the Dose proportionality after single dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •a) Non-smoker, normal, healthy adult male human volunteers between 18 to 45 years of age (both inclusive).
- •b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg per height in meter
- •c) Volunteer should be literate d) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
- •e) Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- •f) Able to give voluntary written informed consent for participation in the trial.
排除标准
- •a) Known hypersensitivity or idiosyncratic reaction to normally used medicines such as antihistamines, NSAIDs or any of the excipients or related drug.
- •b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •c) Ingestion of a medicine (CYP inducers or inhibitors including herbal medicines) at any time within 14 days prior to dosing of part 1/first IMP administration of part 2 and Any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of part 1/ Prior to first dosing in Part
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •e) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •f) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to dosing of part 1/first IMP administration of part
- •g) Smokers, or who have smoked within last six months prior to start of the study.
- •h) The presence of clinically significant abnormal laboratory values including D-Dimer, APTT and PT during screening.
- •i) The presence of clinically significant abnormal laboratory values during screening.
- •j) History or presence of seizure or psychiatric disorders.
- •k) A history of difficulty in donating blood.
- •l) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •m) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication.
- •If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •n) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •o) A positive test result for HIV (1 and/or 2) antibody.
- •p) Consumption of Grapefruits or Grapefruit products within 72 hours prior to dosing of part 1/first IMP administration of part
- •q) A Positive test results for IGRA (Interferon-Gamma Release Assays) (for Tuberculosis) at screening.
- •r) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to dosing of part 1/first IMP administration of part
- •s) History of, or evidence of, active or latent tuberculosis; had a history of diabetes or lymphoproliferative disease or evidence of immunosuppression.
- •t) Subjects on steroids or any anti-inflammatory drugs.
结局指标
主要结局
Single Ascending Dose (SAD)-To evaluate the safety and tolerability of the Different dose levels of MKP 11093 after single-dose administration
时间窗: SAD study - pre dose (0.000) and at 0.500, 1.000, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000 and 72.000 hours post dose. | MAD study-Pre-dose samples: (Total 6 samples) (Morning dose) On Day 01, Day 05, Day 06, Day 07, Day 13 and Day 14 prior to dosing | Post-dose sample (Morning dose) (Day 01) (Total 20 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000 and 24.000 hours | Post-dose sample (Morning dose) (Day 14) (Total 21 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000, 24.000, 48.000 and 72.000
Multiple Ascending Dose (MAD)-To evaluate the safety and tolerability of the Different dose levels of MKP 11093 after multiple-dose administration
时间窗: SAD study - pre dose (0.000) and at 0.500, 1.000, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000 and 72.000 hours post dose. | MAD study-Pre-dose samples: (Total 6 samples) (Morning dose) On Day 01, Day 05, Day 06, Day 07, Day 13 and Day 14 prior to dosing | Post-dose sample (Morning dose) (Day 01) (Total 20 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000 and 24.000 hours | Post-dose sample (Morning dose) (Day 14) (Total 21 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000, 24.000, 48.000 and 72.000
次要结局
- Single Ascending Dose (SAD)-To characterize the single-dose pharmacokinetic profiles of MKP 11093 in human subjects and to evaluate the Dose proportionality after single dose.
研究者
Dr Shrikrishna Kolte
Lambda Therapeutic Research Ltd