None listed
Conditions
Interventions
Intervention1: LifeViroTreat (Chlorine 1mg/m3): Group 1: 2 Subjects will be administered test product as single inhalation dose (nebulized) for 5 min.
Group 2: 2 Subjects will be administered test p
Sponsors
Supreme Industries India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult, human, Subject between the age of 18 years and 50 years Subject will be consider healthy who are fit by a)History 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify maximum tolerable dose of â??Chlorineâ?? in healthy, adult, human subjects.Timepoint: 1 day, 3 days and 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety, tolerability of dose administered in healthy, adult, human subjects. To evaluate the AE profile of the subjects related to the product.Timepoint: 1 day, 3 days and 5 days. | — |
Countries
India
Contacts
Public ContactDr Nileshkumar Patel
Panexcell Clinical Lab Private Limited.
Outcome results
None listed