| CTRI Number |
CTRI/2025/01/079802 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to Study the Safety and Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult Female Volunteers. |
|
Scientific Title of Study
|
A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult Female Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-VIR-003 Version 1.0 Dated 09-Apr-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepalakshmi Rao |
| Designation |
Investigator |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd. |
| Address |
BioRadius Therapeutic Research Pvt. Ltd., 1st Floor, Volunteer study center, IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I, Pune- 411057, Maharashtra, India
Pune
MAHARASHTRA
411057
India |
| Phone |
|
| Fax |
|
| Email |
deepalakshmirao3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, Second Floor, Highland Corporate Center,Kapurbawdi Junction, Thane (W),Maharashtra
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, Second Floor, Highland Corporate Center,Kapurbawdi Junction, Thane (W),Maharashtra
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Viridis BioPharma Pvt. Ltd
1503, Universal Majestic, opp
RBK International academy, P.L.Lokhande Marg, Govandi, Mumbai, 400043 |
|
|
Primary Sponsor
|
| Name |
Viridis BioPharma Pvt Ltd |
| Address |
1503, Universal Majestic, opp
RBK International academy, P.L.Lokhande Marg, Govandi, Mumbai, 400043 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biosphere Clinical Research Pvt Ltd |
SB - 02, 03 & 04, Second Floor,
Highland Corporate Centre,
Kapurbawadi Junction, Thane (W) - 400607,
Maharashtra, India.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepalakshmi Rao |
BioRadius Therapeutic Research Pvt. Ltd., |
IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I, Pune- 411057, Maharashtra, India
Pune
MAHARASHTRA |
8976727555
deepalakshmirao3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vaginitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Colloidal Nano Silver Gel (SilverSol®) |
Internal Application: The dose is 4 gm of gel, once daily at bedtime, inserted into the vagina using an applicator device for a period of 14 days.
Topical Application: 2 gm of gel, twice a day, applied topically using an applicator device on the vaginal area for a period of 14 days.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
- Healthy Adult female subjects between 18 to 40 years of age (Both Inclusive).
- Body Mass Index (BMI) between 18.50–30.00 Kg/m2.
- Healthy female subjects as evaluated by personal history, medical history, medical examination, and gynaecological examination at screening visit.
- Subjects with normal menstrual history with regular cycles with a minimum of 21 days between menses.
- Volunteer with Laboratory evaluations within normal range or clinically non-significant at screening visit.
- Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen and Hepatitis C antibody.
- Non-smoker.
- Normal PAP smear result.
- Volunteer who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- Volunteer who can provide adequate evidence of their identity.
- Volunteer who are willing to abstain from sexual intercourse or use a reliable method of contraception during the study.
- Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test performed within 21 days prior to initiation of the study. |
|
| ExclusionCriteria |
| Details |
- History of or known sensitivity/allergy to any component of study product.
- Volunteer Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3 months.
- Volunteer with Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening.
- Presence of any clinically significant genital epithelial findings such as abrasions, ulcerations, lacerations at screening.
- Have an abnormal PAP test performed at the time of screening.
- Presence of any other clinically significant abnormal physical finding on the vulva, vaginal walls or cervix at screening.
- Volunteer with any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major diagnosed disease or malignancy.
- History of hysterectomy or menopause.
- History of gynaecological surgery or procedure within past 2 months.
- Received systemic or intravaginal antifungal, antibacterial or anti-parasitic drugs within 14 days prior to the first application of study medication.
- History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months, including break-through bleeding requiring sanitary protection.
- Known history of HIV, HCV and HBsAg.
- Known current alcohol abuse and Consumption of alcohol within 48.00 hours prior to check in or difficulty in abstaining from alcohol for the duration of the study.
- History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the in-house stay and history of consumption of caffeine and /or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for at least 24.00 hours prior to check-in.
- History of Consumption of tobacco and tobacco containing products, grapefruit and its juices for at least 48.00 hours prior to check in.
- Intake of OTC products, herbal medications, etc. within 7 days prior to check-in.
- Intake of any prescription medications within 14 days prior to check-in that could affect the kinetics or dynamics of study medications in view of investigator.
- An unusual diet for whatever reason (e.g. low sodium diet) for three weeks prior to check-in.
- Donation or significant loss of whole blood (480 mL or more) within 30 days or serum within 14 days prior to screening.
- Participation in any other clinical research trial involving investigational or marketed products currently or within 90 days of participation prior to screening.
- Any other condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
- Unable to comply with study requirements, including but not limited to, attending all study visits, using the gel as directed, observing abstinence throughout the study and use of effective contraceptives.
- Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to check in.
- Personal or family history of muscular disorders.
- Volunteer having any deformity that will affect venous access for cannulation.
- eGFR less than 60 ml/min.
- Female who is pregnant or lactating, or plans to become pregnant during the study.
- Female whose last menstrual period (LMP) is 21 days prior to initiation of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The assessment of safety and tolerability will be based on the frequency of adverse events and local tolerance. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic evaluation of Colloidal Nano Silver. |
Day 1:
- At 00.00 hours within 01.00 hour prior to intra vaginal application.
- At 02.00, 04.00, 06.00, 08.00, 12.00 & 24.00 hours Post intra vaginal application.
Day 14:
- At 00.00 hours within 01.00 hour prior to intra vaginal application.
- At 02.00, 04.00, 06.00, 08.00, 12.00 & 24.00 hours Post intra vaginal application.
|
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
09/02/2025 |
| Date of Study Completion (India) |
06/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult Female Subjects.
Study objective: Primary objective: The primary objective of the study is to assess the safety of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult female subjects. Secondary objective: The secondary objective of the study is to assess the Pharmacokinetics of Colloidal Nano Silver Gel (SilverSol®) in Healthy Adult female subjects.
Study endpoint: -The assessment of safety and tolerability will be based on the frequency of adverse events and local tolerance. -Pharmacokinetic evaluation of Colloidal Nano Silver.
|