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 Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 m2.
- •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;
- •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 4-10.
- •e) Rectal bleeding score (based on subject diary) of 1 or more at baseline.
- •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 (21â??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.
- •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. Sitting blood pressure less than 110/70 mm Hg and/or more than 140/90 mm Hg at the time of screening.
- •d. 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.
- •e. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •f. Consumption of Grapefruits or its products within a period of 72 hours prior to first IMP administration.
- •g. 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.
- •h. Smokers or who have smoked within last 06 months prior to start of the study.
- •i. Difficulty in swallowing solids dosage forms like capsule or tablets.
- •j. The presence of clinically significant abnormal laboratory values during screening.
- •k. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •l. A history of difficulty with donating blood.
- •m. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •n. 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.
- •o. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •p. A positive test result for HIV antibody (I &/or II).
- •q. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to first IMP administration. In any such case subject selection will be at the discretion of the Principal Investigator.
- •r. Nursing mothers (females)
- •s. Females of child bearing potential.
- •For IBD Patients:
- •a. Documented history of proximal or universal ulcerative colitis (pan colitis).
- •b. 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).
- •c. Patients with known allergy to study drugs or have a history of serious AEs related to their use.
- •d. Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or de
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