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临床试验/CTRI/2019/12/022266
CTRI/2019/12/022266招募中1 期

A Placebo-controlled, Randomized, Double Blind, Multiple Ascending Dose, Multiple Cohort, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics & Efficacy of PNB-001 (Test, Manufactured by PNB Vesper Life Science Pvt. Ltd., India).

PNB Vesper Life Science Pvt Ltd7 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年8月12日最近更新:
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适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
52
试验地点
7
主要终点
Assessment of the safety and tolerability of study drug.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The Sponsor has developed the test product. This study is being conducted to assess the safety, tolerability, pharmacokinetics & efficacy of PNB-001 after multiple ascending dose of PNB-001.The current study is a placebo-controlled, randomized, double blind, multiple ascending dose, multicentre study. The study will be conducted in multiple cohorts. It is a descriptive study to evaluate multiple-dose safety and tolerability and to estimate dose-limiting toxicity, if any, of multiple oral doses. Doses selected for the study range from 50 mg to 200 mg BID. Animal models suggest the anti-inflammatory and analgesic potential of PNB-001. To evaluate these properties of PNB-001 in patient population the current study will involve two patient based cohorts one each of ulcerative colitis and dysmenorrhea wherein the efficacy of the molecule will be evaluated. A total of 52 subjects will be enrolled into the study. The study will commence only after a written approval is obtained from the Institutional Review Board and written informed consent given by the subjects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)（—）
性别
All

入选标准

  • •For Healthy subjects: a) Non-smokers, Healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).
  • •b) Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/height in m
  • •c) Have no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
  • •d) Able to understand and comply with the study procedures, in the opinion of the investigator.
  • •e) Able to give voluntary informed consent for participation in the trial.
  • •f) In case of female subjects: i.
  • •Surgically sterilized at least 6 months prior to study participation; And ii.
  • •Serum pregnancy test must be negative For IBD Patients: a) Male patients are eligible, if they are ≥ 18 years and ≤ 65 years of age.
  • •b) Patients have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole/part of left side of the colon [approximately 60 cm up from the anus (anal verge) to splenic flexure of colon], with mild to moderate active disease.
  • •c) Patients having ESR, CRP and FC levels more than upper limit of normal.
  • •d) Patients with a Full Ulcerative Colitis Disease Activity Index (UCDAI) score of 4-
  • •f) Mucosal appearance score (based on endoscopy) of 1 point or more at baseline.
  • •g) Stool Frequency subscore of 1 or more at baseline.
  • •h) Patients who have failed to achieve total resolution of all symptoms to topical and/or oral standard treatment regimen of mesalamine over minimum 4 week duration and are in need of an alternative therapy as per the discretion of the Investigator.
  • •i) Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening until 4 weeks after the last dose of study medication..
  • •j) They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
  • •k) Subjects with acceptable laboratory parameters.
  • •For dysmenorrhoea (surgically sterilized females) Patients: a) Females with regular cycles (21–35 days) with duration of 3 to 7 days.
  • •b) Females with primary dysmenorrhea.
  • •c) Females who are surgically sterile.
  • •d) Patients with moderate to severe pain on visual analogue scale (VAS ≥45 mm) in the current and previous 3 menstrual cycles, necessitating the use of analgesics.
  • •e) Pain lasting for at least 2 days.
  • •f) Willing to provide written informed consent.

排除标准

  • •For Healthy subjects: a.
  • •Known hypersensitivity or idiosyncratic reaction to cholecystokinin receptor antagonist or to any of its excipients or any drug or any substance.
  • •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.
  • •Sitting blood pressure less than 110/70 mm Hg and/or more than 140/90 mm Hg at the time of screening.
  • •Ingestion of a medicine [prescribed & over the counter (OTC) medication including herbal remedies] at any time within 2 weeks before first dosing (4 weeks for any drug which may affect hepatic drug metabolism).
  • •In any such case subject selection will be at the discretion of the Principal Investigator.
  • •Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
  • •Consumption of Grapefruits or its products within a period of 72 hours prior to first IMP administration.
  • •A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (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 first IMP administration.
  • •Smokers or who have smoked within last 06 months prior to start of the study.
  • •Difficulty in swallowing solids dosage forms like capsule or tablets.
  • •The presence of clinically significant abnormal laboratory values during screening.
  • •Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
  • •A history of difficulty with donating blood.
  • •Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
  • •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.
  • •A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
  • •A positive test result for HIV antibody (I &/or II).
  • •Nursing mothers (females) s.
  • •Females of child bearing potential.
  • •For IBD Patients: a.
  • •Documented history of proximal or universal ulcerative colitis (pan colitis).
  • •Those who receive a Physician rating of disease severity of 3 as part of the modified UCDAI or Full UCDAI aggregate score of 11 or greater (severe disease).
  • •Patients with known allergy to study drugs or have a history of serious AEs related to their use.
  • •Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
  • •Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
  • •Patient whose stool contains enteric pathogens or Clostridium difficile toxins.
  • •History of recurrent Clostridium difficile infection.
  • •History of biological therapy with agents like infliximab, adalimumab, etanercept, etc.
  • •Patients who received systemic steroids or immunosuppressants within the previous 4 weeks of screening.
  • •Treatment in the last 1 week of screening that included antibiotic, antifungal, or antiparasitic medications.
  • •Patients having a history of cancer (defined as malignancy), asthma, or bronchospasm.
  • •Patients not able to withdraw and in need of continuing other immunosuppressants like sirolimus or cyclosporine during the study period.
  • •There is evidence of chemical substance abuse.
  • •Patients with Crohn disease.
  • •Patients with HIV, Hepatitis B and Hepatitis C infection.
  • •Patients with pre existent renal function disorders, liver function disorders, cardiac disease, hypertension, clinically important hematological, metabolic, psychiatric, central nervous system or pulmonary disease.
  • •Patients who participated in any other clinical or post-marketing study (not only for study drugs but also for medical devices) 30 days before signing the informed consent.
  • •Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
  • •For Dysmenorrhoea (surgically sterilized females) Patients: a.
  • •Hypersensitivity to the study medications.
  • •Active or suspected gastrointestinal ulcer, chronic dyspepsia, or gastrointestinal bleeding; Crohn’s disease or ulcerative colitis; history of significant chronic constipation or recurrent colitis.
  • •History of bronchial asthma.
  • •Severe heart failure.
  • •Moderate-to-severe renal function (GFR < 60 mL/min).
  • •Hemorrhagic diathesis and other coagulation disorders.
  • •Contraindication to use of PNB-
  • •Diagnosed gastrointestinal obstruction; myasthenia gravis; glaucoma.
  • •Known or suspected secondary dysmenorrheal.
  • 另有 2 项未显示

结局指标

主要结局

Assessment of the safety and tolerability of study drug.

时间窗: Through out the study

次要结局

  • Assessment of pharmacokinetics and efficacy of study drug.(Pre-dose)

研究者

发起方
PNB Vesper Life Science Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (7)

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