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CTRI Number  CTRI/2025/12/099939 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 05/03/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study   Nutraceutical study 
Study Design  Single Arm Study 
Public Title of Study   Oral bioavailability study of test product to evaluate the safety, tolerability, and Pharmacokinetics in healthy human subjects. 
Scientific Title of Study   An open-label, single treatment, single period, bioavailability study to evaluate the safety, tolerability and Pharmacokinetics of DOPS-F02 of LipoSeuticals Inc. USA, following a single intravenous infusion in healthy adult human subjects under fasting condition 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
DOPS-116-25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Srinivas 
Designation  Principal investigator 
Affiliation  Actimus Biosciences Private Limited 
Address  D-2, D-block, Autonagar, Gajuwaka,
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530012
India 
Phone  9154162270  
Fax    
Email  ksrinivas@actimusbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Srinivas 
Designation  Principal investigator 
Affiliation  Actimus Biosciences Private Limited 
Address  D-2, D-block, Autonagar, Gajuwaka,
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530012
India 
Phone  9154162270  
Fax    
Email  ksrinivas@actimusbio.com  
 
Details of Contact Person
Public Query  
Name  Dr K Srinivas 
Designation  Principal investigator 
Affiliation  Actimus Biosciences Private Limited 
Address  D-2, D-block, Autonagar, Gajuwaka,
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530012
India 
Phone  9154162270  
Fax    
Email  ksrinivas@actimusbio.com  
 
Source of Monetary or Material Support  
LipoSeuticals Inc., 11 Deerpark Drive, Suite 121, Monmouth Junction, NJ 08852, USA. 
 
Primary Sponsor  
Name  LipoSeuticals Inc 
Address  11 Deerpark Drive, Suite 121, Monmouth Junction, NJ 08852, USA. Phone No.: 001 (732) 823-1558 and (609) 937 4175. Email: wun@li12oseuticals.com 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Srinivas  Actimus Biosciences Pvt. Ltd.  Actimus Biosciences Private Limited, D-2, D-block, Autonagar, Gajuwaka, Visakhapatnam-530012
Visakhapatnam
ANDHRA PRADESH 		 9154162270

ksrinivas@actimusbio.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Visakha institutional review board  Approved 
Visakha institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DOPS-F02 in sterile saline (0.9% sodium chloride)  Name: DOPS-F02 in in sterile saline (0.9% sodium chloride) Dosage form: single intravenous (1.V.) dose Total duration of intervention is atleast 5 days. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Subjects who are able to understand and provide written informed consent.
2. Subjects must be normal healthy, adult, human beings within 18–55 years of age (both
inclusive and weighing at least 50 kgs and not more than 100 kgs (both are inclusive).
3. Having a body mass index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in Kg/height in m2.
4. Subjects must be of normal health as determined by medical history and physical examination performed within 28 days prior to the IP administration.
5. Have normal ECG, chest X-ray and vital signs [body temperature 95.0ºF (35ºC) to 98.6ºF (37ºC), pulse rate 60 to 100 per minute, systolic blood pressure 100 to 140 mm/Hg, diastolic blood pressure 60 to 90 mm/Hg, respiratory rate 14 to 20 per min and SpO2 levels-95% to 100%].
6. Subjects whose screening laboratory values are within normal limits or laboratory abnormalities considered by the investigator to be of no clinical significance.
7. Subjects who pass the skin prick test prior to check-in.
8. Subjects who are non-smokers and non-alcoholics.
9. Availability of the subject for the entire study period and willingness to adhere to the
protocol requirements as evidenced by written informed consent.
10. If study participant is male volunteer and willing to follow approved birth control
methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, vasectomized. Subjects should not donate sperm during this time.
11. If study participant is a female volunteer and is of child bearing potential practicing an
acceptable method of birth control for the duration of the study as judged by the
investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD).
(or) abstinence (or) is postmenopausal for at least 1 year or is surgically sterile
(bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the study participant).
12. Female study participant should be negative in pregnancy test at screening, check-in and at post study safety assessment. 
 
ExclusionCriteria 
Details  1. History of hypersensitivity (or) idiosyncratic reaction to DOPS-F02 or any other similar products.
2. Subjects with history or presence of significant cardiovascular, pulmonary, hepatic,
hematological, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
3. Subject who are positive for HIV antibody, HCV, Hepatitis B surface antigen or RPR.
4. Subjects who have consumed alcohol, gutkha, pan masala and tobacco products 48.00 hours prior to check-in of study period and until completion of the study.
5. Subjects who have taken any xanthine containing food or beverages (like tea, coffee, chocolates or cola drinks) 48.00 hours check-in of study period and until completion of the study.
6. Subjects who are pregnant (for females only), unstable asthma or those taking betablockers
and/or ACE inhibitors.
7. Subjects who have taken any antihistamines (H1 blockers), tricyclic antidepressants,
topical corticosteroids (which may inhibit skin prick test reactions) 72.00 hours prior
to check-in of study period.
8. Subjects with history of hypersensitivity reactions to PEG or PEG-Containing Products.
9. Subjects with history of known hypersensitivity reactions during COVID-19 vaccination.
10. Consumption of grapefruit or its products for the past 03 days prior to the study
initiation and until completion of the study.
11. Subjects who have taken over the counter (OTC) or enzyme modifying medication or
any prescribed medications (including herbal preparation) during the last 07 days of
study initiation and until completion of the study.
12. Study participants who have participated in any other clinical investigation using
experimental drug or had blood loss of more than 350 mL at single occasion in the past 90 days.
13. Study participants with positive alcohol test and positive urine screen for drugs of abuse at the time of check-in.
14. Study participants with abnormal ranges (clinically significant) in clinical
investigations at the time of check-in.
15. Subject who are suffering from diarrhea in the last 24.00 hours, which leads to dehydration.
16. Female subjects who are pregnant (women with childbearing potential) or planning to become pregnant during the study.
17. Female volunteers who are in lactation period at the time of admission for study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the safety and tolerability of a single intravenous (1.V.) dose
of DOPS-F02. 		 1. Electrocardiogram (ECG) will be performed on the day of admission at
the time of fitness assessment and at 6.00, 12.00 hours post-dose within a
window period of± 45 minutes for post-dose from the schedule time and
at post study safety assessment.
2. Lactate Dehydrogenase (LDH), Clinical Laboratory Tests includes
Hematology, Biochemistry, and Urinalysis will be evaluated prior to
check-in and at 24.00, 48.00 and 72.00 hours post dose.
3. Injection site assessment will be performed prior to dosing, during
dosing, and up to one hour after dose administration.
4. Clinical monitoring of subjects will be conducted up to 72 hours postdose,
including the recording of adverse events, physical examinations,
vital signs ((blood pressure, pulse rate, respiratory rate, SpO2, body
temperature), Clinical Laboratory Tests includes Hematology,
Biochemistry and Urinalysis based on the investigator discretion. 
 
Secondary Outcome  
Outcome  TimePoints 
To characterize the pharmacokinetic profile of the DOPS-F02.  Pre-dose samples will be collected at 0.00 (within 01 hour prior to dose
administration) and the post-dose samples will be collected at 0.25, 0.50,
0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00,
48.00 and 72.00 hours after dosing into 3 mL K2EDTA vacutainers. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="16"
Sample Size from India="16" 
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   N/A 
Date of First Enrollment (India)   15/01/2026 
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="0"
Days="5" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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
Modification(s)  		 This is an open-label, single treatment, single period, bioavailability study to evaluate the safety, tolerability and Pharmacokinetics of DOPS-F02 of LipoSeuticals Inc. USA, following a single intravenous infusion in healthy adult human subjects under fasting condition. The primary objective of the study is To evaluate the safety and tolerability of a single intravenous dose of DOPS-F02 and the secondary objective is to characterize the pharmacokinetic profile of the DOPS-F02.  The total of 16 subjects will be enrolled into the study. The investigational product will be DOPS-F02 in Saline (0.9% Sodium Chloride, Sterile). The subjects will be housed in the facility 11.00 hours before dosing and 72.00 hours after dosing. The total duration of the study will be at least 05 days. 
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