| CTRI Number |
CTRI/2024/11/076824 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate
Cerebrospinal Fluid Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy Adult Subjects |
|
Scientific Title of Study
|
A Single Arm, Open Label, Single Dose Study to Evaluate
Cerebrospinal Fluid Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy Adult Subjects |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICS/LAX/2023-002 Version 1.0 Date 28 JUL 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Das |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
ICBio Clinical Research Private limited
Department of Clinical Research, #16&18, ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura India
Bangalore
KARNATAKA
560097
India |
| Phone |
8023641042 |
| Fax |
|
| Email |
drankitadas84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Kartik Sahn |
| Designation |
Director |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512,Clinical Trial Division, Clinical Operations Department,
Best Sky Tower,
Netaji Subhash Place, Pitampura
North West
DELHI
110034
India |
| Phone |
9868679414 |
| Fax |
|
| Email |
kartik.sahni@insigniacs.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Kartik Sahn |
| Designation |
Director |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512,Clinical Trial Division, Clinical Operations Department,
Best Sky Tower,
Netaji Subhash Place, Pitampura
North West
DELHI
110034
India |
| Phone |
9868679414 |
| Fax |
|
| Email |
kartik.sahni@insigniacs.com |
|
|
Source of Monetary or Material Support
|
| One O One Therapeutics
Menachem Begin Rd. 121, Floor 57, Tel Aviv-Yafo, Israel |
|
|
Primary Sponsor
|
| Name |
Laxai Life Sciences Pvt. Ltd |
| Address |
Ltd Plot #40 & 41, 3rd Floor, Ventureast Plaza,Financial District, Nanakramguda, R R District, Telangana-500032. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| One O One Therapeutics |
Menachem Begin Rd. 121, Floor 57, Tel Aviv-Yafo, Israel |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Das |
ICBio Clinical Research Private limited |
Department of Clinical Research, Ground Floor, Room No 001 (Research Division)
#16&18, ICBio Tower, Yelahanka Main Road, Chikkabetahalli,
Vidyaranyapura 560097 India
Bangalore
KARNATAKA |
8023641042
drankitadas84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
101-PGC-005 |
Bolus Injection containing 30mg of 101-PGC-005 will be
administered once on Day 1 of the study |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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, amphetamines, barbiturates, cocaine, methadone, phencyclidine, 3,4 methylenedioxymethamphetamine MDMA ecstasy,
tetrahydrocannabinol, and opiates) in urine
23. Consumption of xanthine or its derivative containing food or beverages e.g. chocolates, tea, coffee or cola drinks within 48.00 hours prior to dosing in each study period and throughout sampling time points.
24. Lactating or nursing female subjects.
25. Female subjects using hormonal contraceptive either oral or implants.
26. History of allergy or hypersensitivity intolerance to Dexamethasone or its formulation excipients which, in the opinion of the clinical investigator, would compromise the safety of the subject or the study.
27. Any history of difficulty in blood sampling or any vasovagal attack during blood sampling which in the opinion of the Investigator may relevantly interfere with the study sampling.
28. Evidence of an uncooperative attitude |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 1 |
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 Outcome
|
| Outcome |
TimePoints |
| To monitor the overall safety & tolerability profile of the 101-PGC-005 injection in healthy adult human subjects under fasting conditions. |
Throughout study duration |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus Disease-2019 COVID-19 is a lethal infectious disease that was reported in Wuhan, Hubei Province, China, and it has been rapidly spreading throughout the world. The novel coronavirus disease has caused more than 6.5 million deaths to date. The majority of COVID-19 infections are either asymptomatic or result in mild disease. However, a substantial proportion of older infected individuals do develop a respiratory illness that requires hospitalization. COVID-19 can rapidly progress to critical illness with hypoxemic respiratory failure and require prolonged ventilatory support. The pathophysiology of severe COVID-19 is dominated by an acute pneumonic process with extensive radiological opacity. On autopsy, diffuse alveolar damage, inflammatory infiltrates, and microvascular thrombosis is evident. The host immune response is thought to play a key role in avian influenza, severe acute respiratory syndrome SARS, and both pandemic and seasonal influenza. Inflammatory organ injury may occur in severe COVID-19, with a subset of patients having markedly elevated inflammatory markers such as Creactive protein, ferritin, TNF-alpha, Interleukins IL-1, and IL-6. Several therapeutic interventions to mitigate inflammatory organ injury have been proposed for both the treatment of viral pneumonia and neurological complications, but the value of corticosteroids is widely debated due to the overall side effects of these steroids on the body |