None listed
Conditions
Interventions
Intervention1: 101-PGC-005: Bolus Injection containing 30mg of 101-PGC-005 will be
administered once on Day 1 of the study
Control Intervention1: NA: NA
Control Intervention2: Not Applicable: Not App
Sponsors
Laxai Life Sciences Pvt. Ltd
One O One Therapeutics
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to provide audio-visual & written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2. Willing to be available for the entire study period and to comply with protocol requirements. Should have reliable access to the clinical trial center and available in the area for at least one month. 3. Normal, healthy, adult, human subject of 18 to 45 years both inclusive of age. 4. Body mass index in the range of 18 to 30 kgm2 both inclusive. 5. Normal haemoglobin between 12.5 to 17.5 grams per deciliter gdL for men and 12.0 to 16.0 gdL for female. 6. Non diabetic health adult with HbA1c less than 5.5 at the time of study entry. 7. Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check in during each study period. 8. With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis. 9. With a normal or clinically non-significant 12-lead ECG. 10. With a negative test for Human Immunodeficiency Virus HIV type I type II antibodies or Hepatitis B surface antigen HBsAg or Hepatitis C virus antibodies. 11. In case of female subjects a. Negative urine pregnancy test during screening OR post menopausal or surgically sterile female subjects is allowed. Note Postmenopausal is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels more than 40 mIU per ml, or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. b. They should not be on their menstrual period on the day of the blood draw. 12. Ability to communicate effectively
Exclusion criteria
Exclusion criteria: 1. Found positive PCR test for COVID 19 during screening. 2. Hemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 3. Has consumed dexamethasone or any other corticosteroid oral or intravenous for any reasons in past 4 weeks before study entry. 4. Any medical or surgical conditions, which might significantly interfere with the normal functioning of the body organs. 5. History of severe infection or major surgery in the past 6 months. 6. History of Minor surgery or fracture within the past 3 months. 7. Significant history or current evidence of malignancy or chronic infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic endocrine, hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 8. History of medical or surgical conditions in which lumbar puncture is contraindicated or likely difficult access to the lumbar sack, such as prior lumbar surgery, lumbar stenosis, significant osteoarthritis or clinically significant congenital deformities of the spine, history of frequent headache, intracranial or intraspinal pathology. 9.Any major illness or hospitalized within 90 days prior to the first dosing. 10.Any other clinical condition like diarrhea or vomiting within three days prior to dosing. 11. Subjects who have been on an unusual or abnormal diet, for whatever reason e.g because of fasting due to religious reasons during the four weeks before screening. 12. Use of any depot injection or an implant of any drug within three months prior to dosing and throughout the study periods. 13. Use of any prescribed medication including herbal medicines and vitamin supplements within 14 days or within five halflives of the drug, whichever is longer prior to dosing and throughout the study. 14. Use of any OTC products within 7 days or within five halflives of the drug, whichever is longer prior to dosing and throughout the study. 15. History or presence of significant gastric or duodenal ulceration. 16. Use of any recreational drug or history of drug addiction. 17.Participated in any clinical investigation requiring repeated blood sampling, blood donation, or have blood loss of more than 500 mL in past 90 days prior to dosing. 18. Participated in any clinical study within the past 90 days prior to first dosing. 19. Use of any Investigational vaccine within the last five years except for Covid19 vaccines. 20. History of Chronic systemic immunosuppressive medications usage for any reasons. 21. Consumption of alcohol or alcoholic products within 72.00 hrs prior to dosing in each study period and throughout sampling time points. 22. Positive alcohol breath or urine screen for drug of abuse tests during check in study period. a. Current smokers, or those who gave up smoking less than 3 months prior to screening ,thus 3 months cessation required at screening time, including alternative tobacco products such as chewing tobacco and vaping, or positive in the urine cotinine test at screening. b. Positive test for alcohol in breath, or drugs of abuse including benzodiazepines, amphetamine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of 101-PGC-005 concentration available in cerebrospinal fluid (CSF) and systemic circulation (blood plasma in all recruited subjects, pre- and post- dosing with 101-PGC-005 injection on Day 1Timepoint: Plasma Sample Collection: within 30 min. pre-dose and 30 min., 1, 2, 3, 6, 9, 12, 24 hours post-dose. point CSF Sample Collection: within 45 min. pre-dose and 45 min., 1.5, 2.5, 3.5, 6.5, 9.5, 12.5, 24.5 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the overall safety & tolerability profile of the 101-PGC-005 injection in healthy adult human subjects under fasting conditions.Timepoint: Throughout study duration | — |
Countries
India
Contacts
Public ContactMr Kartik Sahn
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed