| CTRI Number |
CTRI/2025/08/093831 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Oral bioavailability study of test product to evaluate the safety, tolerability, and Pharmacokinetics in healthy subjects. |
|
Scientific Title of Study
|
A two-stage randomized, double blind, two treatment, placebo-controlled, single oral dose study to evaluate the safety, tolerability, and Pharmacokinetics of DOPS-F02 of LipoSeuticals Inc. USA, in healthy adult human subjects under fasting condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Srinivas |
| Designation |
Principal investigator |
| Affiliation |
Actimus Biosciences Private Limited |
| Address |
Actimus Biosciences Private Limited
Clinical research department, D-2, D-block, Autonagar, Gajuwaka
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 |
Actimus Biosciences Private Limited
Clinical Research Department, D-2, D-block, Autonagar, Gajuwaka
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 |
Actimus Biosciences Private Limited
Clinical Research Department, D-2, D-block, Autonagar, Gajuwaka
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. Phone No.: 001 (732) 823-1558 and (609)937 4175 mail: wun@liposeuticals.com |
|
|
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 mail:wun@liposeuticals.com |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
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. |
D-2, D-block, Autonagar, Gajuwaka
Visakhapatnam
ANDHRA PRADESH |
9154162270
ksrinivas@actimusbio.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Visakha institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DOPS-F02 in Mannitol |
Name: DOPS-F02 in Mannitol
Dosage form: capsule
Dose: Single oral dose of 500 mg
Total duration of the study will be at least 05 days. |
| Comparator Agent |
Placebo (Mannitol)
|
Dosage form: capsule
Dose: single oral dose of 500 mg.
Total duration of the study will be at least 05 days. |
|
|
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 for males and 45 kgs for females.
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 are non-smokers and non-alcoholics.
8. Availability of the subject for the entire study period and willingness to adhere to the
protocol requirements as evidenced by written informed consent.
9. 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.
10. 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).
11. 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 of alcohol, gutkha, pan masala and tobacco products 48.00 hours prior to check-in of Period-I 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 Period-I and until completion of the study.
6. Consumption of grapefruit or its products for the past 03 days prior to the study initiation and until completion of the study.
7. 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.
8. 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.
9. Study participants with positive alcohol test and positive urine screen for drugs of abuse at the time of check-in.
10. Study participants with abnormal ranges (clinically significant) in clinical investigations at the time of check-in.
11. Subject who are suffering from diarrhea in the last 24.00 hours, which leads to dehydration.
12. Female subjects who are pregnant (women with childbearing potential) or planning to become pregnant during the study.
13. Female volunteers who are in lactation period at the time of admission for study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of a single oral dose of DOPS-F02 |
To evaluate the safety and tolerability of a single oral dose of DOPS-F02.
Physical examination, vital signs, ECG, Laboratory parameters and urinalysis will be performed at baseline, during the study and on day 5 (end of the study). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetic profile of the DOPS-F02 |
Blood samples will be collected at 0.00 hours pre-dose and post-dose samples will be collected at 0.50, 1.00, 2.00, 4.00, 8.00, 12.00, 18.00 and 24.00 hours for pharmacokinetic analysis. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2025 |
| 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 Applicable |
| 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
|
This study is designed as a two-stage, randomized, double blind, two treatment, placebo-controlled, single oral dose study to evaluate the safety, tolerability, and Pharmacokinetics of DOPS-F02 in healthy adult human subjects under fasting condition. The study objectives is to evaluate the safety and tolerability of a single oral dose of DOPS-F02 and characterize the pharmacokinetic profile of the DOPS-F02. The total number of the subjects will be 40 subjects (stage 01, 28 subjects and stage 02, 12 subjects). The investigational products is DOPS-F02 in Mannitol capsules as test arm and Placebo (Mannitol) as control arm. An interim analysis will be conducted upon completion of Stage 1 to evaluate the safety and potential benefit of the treatment. The trial may be terminated early if the treatment is found to be clearly ineffective (futility) or poses significant safety concerns. The total study duration will be at least 05 days. |