CTRI/2021/04/033295招募中1 期
A DOSE ESCALATION CLINICAL STUDY OF THE SAFETY AND TOLERABILITY OF INHALED FORMULATIONS OF LIFEVIROTREAT OF SUPREME INDUSTRIES, INDIA IN HEALTHY, ADULT, HUMAN SUBJECTS.
Supreme Industries India0 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
- •1. Healthy adult, human, Subject between the age of 18 years and 50 years
- •Subject will be consider healthy who are fit by
- •b)Sign and symptom free
- •c)No concomitant drug
- •d)Acceptable laboratory test
- •e)Acceptable screening test
- •A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to dosing and negative pregnancy test (by Kit or Serum method) at the time of check-in. Female subject must have a negative pregnancy test prior to check-in. They must be using an acceptable form of contraception.
- •B. For female of childbearing potential, acceptable forms of contraception include the following:
- •i. Non-hormonal intrauterine device in place for at least 3 months prior to the study check-in and remaining in place during the study period, or
- •ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
- •iii. Surgical sterilization
- •iv. Practicing sexual abstinence throughout the course of the study
- •C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- •i. Postmenopausal with spontaneous amenorrhea for at least one year, or
- •ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •iii. Total hysterectomy and an absence of bleeding for at least 3 months.
- •2. BMI between 18.5 to 30 kg/m2
- •3. Subject willing to provide informed consent to participate into the trial.
- •4. Subject willing to use two method of contraception 3 month after enrollment into the study.
- •5. Subject able to comply requirement of study and protocol
排除标准
- •1.Known hypersensitivity or idiosyncratic reaction to any substances.
- •2.Patient having past history of respiratory disorder like COPD, Asthma etc.
- •3.Patient is on medication for respiratory disease or disorder.
- •4.Patient having uncontrolled disorder of any systemic disease.
- •5.History of uncontrolled blood pressure or blood sugar.
- •6.Patients who are diagnosed and/or on treatment for venous thromboembolism, ischemic heart disease, myocardial infarction, congestive cardiac failure, unexplained vaginal bleeding with suspicion of serious underlying condition, history of breast or cervical cancer, malignant tumor
- •7.Use of any recreational drugs or history of drug addiction.
- •8.Have participated in other clinical study.
- •9.Subjects with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.
- •10.Reports of any history of malignancy
- •11.Presence of clinically significant results from laboratory tests, vital signs assessments, X-Ray, electrocardiograms, 2-D ECHO and Pulmonary Function Test for which investigator feels it is not in interest of Subject to participate in a trial.
- •12.Reports a clinically significant illness during the 30 days prior to enrollment.
- •13.Use of any over-the-counter (OTC) drugs 14 days prior to enrollment.
研究者
相似试验
进行中（未招募）
1 期
Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination with Different Treatment Regimens in Subjects with Advanced Solid Tumors (Phase 1b/2; Protocol No. P04722) - N/AColorectal Adenocarcinoma, Non-small Cell Lung Cancer, Gastric Adenocarcinoma, Her2+ Breast Cancer, Renal Cell Cancer, Pancreatic AdenocarcinomaMedDRA version: 12.0 Level: LLT Classification code 10001150 Term: Adenocarcinoma gastricMedDRA version: 12.0 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancerMedDRA version: 12.0 Level: LLT Classification code 10038407 Term: Renal cell cancerMedDRA version: 12.0 Level: LLT Classification code 10051971 Term: Pancreatic adenocarcinomaMedDRA version: 12.0 Level: PT Classification code 10052360 Term: <Manually entered code. Term in E.1.1>MedDRA version: 12.0 Level: PT Classification code 10061873 Term: <Manually entered code. Term in E.1.1>EUCTR2009-011101-16-GBSchering-Plough Research Institute, A Division of Schering Corporation250
已完成
1 期
A programme to develop a skin patch containing two medicines (physostigmine and hyoscine) - study 2: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing four prototype skin patchesPotential risk of poisoning by nerve agentInjury, Occupational Diseases, PoisoningPoisoningISRCTN29062676Defence Science and Technology Laboratory (Dstl)24
招募中
不适用
Dose escalation trial to evaluate the safety and the efficacy on new bone formation of a single local treatment with lithium carbonate to teeth extraction sockets for dental implant in Japanese participantsJPRN-UMIN000008795Kyushu University Hospital12
进行中（未招募）
1 期
A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus VulgarisPemphigus vulgarisMedDRA version: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858EUCTR2018-002146-37-ITINCYTE CORPORATIO18
进行中（未招募）
1 期
A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus VulgarisPemphigus vulgarisMedDRA version: 20.0 Level: LLT Classification code 10052802 Term: Pemphigus vulgaris System Organ Class: 100000004858EUCTR2018-002146-37-FRIncyte Corporation18