An Open-Label, Balanced, Randomized, Single Ascending Dose Study, To Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate (L-S-MTHF) Following Oral Administration Of Different Dose Levels of CreNeuroS® CNS Fish Oil Plus Softgels Supplied By Sichuan Credit Pharmaceutical Co., Ltd, China in Healthy Subjects Under Fasting Conditions
Phase: NA
Conditions: Bioavailability and Pharmacokinetics
Sponsor: Sichuan Credit Pharmaceutical Co., Ltd.

STUDY PROTOCOL 
Study Protocol No.: 
SLS-BE-O 14S-2S-CREN 
Version No: 
01 
Date: 
21 Jan 26 
Single 
ascending dose 
(SAD) study with 
Dose 
Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate 
(L-S-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
1. PROTOCOL SUMMARY 
Study Title 
Investigational 
Medicinal 
Products 
Objectives 
An Open-Label, Balanced, Randomized, Single Ascending Dose Study, To 
Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid (EPA) and 
Calcium L-S-Methyltetrahydrofolate (L-S-MTHF) Following Oral Administration 
Of Different Dose Levels of Crenueros® CNS Fish Oil Plus Softgels Supplied By 
Sichuan Credit Pharmaceutical Co., Ltd, China in Healthy Subjects Under Fasting 
Conditions. 
Test Product (T): 
Primary Objective: 
CreNeuroS® CNS Fish Oil Plus Softgels Supplied by 
Sichuan Credit Pharmaceutical Co., Ltd, China. 
Each softgel contains, 
Eicosapentaenoic Acid (EPA) (as EE) 400 mg; 
Calcium L-S-Methyltetrahydrofolate 3.75 mg and 
other Vitamins and Minerals. 
• 
To assess the Pharmacokinetic profile of single ascending doses of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate (L-
S-MTHF) after administration of CreNeuroS® CNS Fish Oil Plus Softgels in 
healthy subjects under fasting condition. 
• 
To demonstrate dose linearity of Eicosapentaenoic Acid (EPA) and Calcium 
L-S-Methyltetrahydrofolate 
(L-S-MTHF) 
following 
single 
dose 
administration (different doses) of CreNeuroS® CNS Fish Oil Plus Softgels 
in healthy subjects under fasting condition. 
Secondary objective: 
To evaluate the safety and tolerability of single ascending doses (different doses) of 
CreNeuroS® CNS Fish Oil Plus Softgels 
111 healthy subjects under fasting 
condition. 
This document is strict~l' confidential and it is 1II/ intellectual property of Spb/Os Life Sciellce and Research Private Limited al/d Sichuan 
Credit PharmaceuticlIl Co., Ltd, CMf/II. This should /lOt be disclosed to af/y third party, with tlte etception of regulatory bodies alii! study 
audit personal Reproduction, modificlltion or at/aptatiof/, in part or ill total is strictly forbidt/ef/ witltout prior written approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 8 of 76 
27 JAN '2026 

Study Design 
Regulatory 
Submission 
Sample Size 
Primary 
Em"ollment 
criteria 
Housing 
STUDY PROTOCOL 
Study Protocol No.: 
Version No: 
Date: 
SLS-BE-014S-2S-CREN 
01 
21 Jan 26 
Single 
ascending dose 
(SAD) 
study with 
Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate 
(L-S-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
An Open-Label, Balanced, Randomized, Single ascending dose study to evaluate 
the Pharmacokinetic dose linearity in healthy subjects under fasting condition. 
NMPA (National Medical Products Administration) - Pivotal 
At least 32 number of healthy, human subjects will be recruited to evaluate the 
Pharmacokinetic dose linearity in healthy subjects. 
Note: A total of 32 subjects (8 subjects in each groups) will be enrolled in this 
study. 
SAD Cohort 
Number of subjects 
1 
08 Subjects 
2 
08 Subjects 
3 
08 Subjects 
4 
08 Subjects 
As per the discretion of the Investigator, a sufficient number of stand-by subjects 
will be included additionally to ensure successful dosing of 08 subjects in each 
cohorts during the study period. 
Demographic data, medical and medication history, physical examination, 12-lead 
ECG, haemato\ogy, biochemistry, serology, urine routine analysis, additionally for 
females serum pregnancy test, hormone assay (FSH) will be done within 21 days 
and a chest X-ray within 06 months prior to check-in. 
In study period, each group subjects will be housed in the clinical facility for at 
least -60.00 hours pre-dose to 72.00 hours post-dose. 
Note: 
Dosing will be done individually for each cohort groups (Cohort 01, Cohort 02, 
Cohort 03, Cohort 04). The subsequent group's check-in will be at the check-
out day of the previous group. 
Tltis documelll i~ strict~l' confidelltiallllld it is all intellectual property of Spinos Life Sciellce alld Researclt Private Limited alld Sichuall 
Credit Pharmaceutical Co., Ltd, China. Tltis should 1I0t be (lisclosed to an)' third party, with the exception of regulatory bodies ami study 
audit personal. Reproduction, modification or adaptation, ill part or ill total is strictly forbidden without prior written approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 9 of 76 
JAN 2026 

STUDY PROTOCOL 
Study Pl'Otocol No.: 
Version No: 
Date: 
SLS-BE-0145-25-CREN 
01 
21 Jan 26 
Single 
ascending dose 
(SAD) study 
with 
Dose 
Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate 
(L-5-MTHF) following oral administration of different dose levels of 
CreNeuroS@ CNS Fish Oil Plus Softgels under fasting condition. 
Fasting condition 
Standard meals will be provided starting -59.00, -48.00, -44.00, -40.00, -36.00, -
24.00, -20.00, -16.00, -12.00 hours. Thereafter, subjects will be fasted for at least 
08.00 hours prior to dosing. Standard meals will be provided starting at 04.00, 
08.00, 12.00, 24.00, 28.00, 32.00, 36.00, 48.00, 52.00, 56.00 and 60.00 hours post-
dose respectively. 
Dose and Mode of In study period, after an overnight fasting of at least 08.00 hours, in the morning a 
Administration 
single oral dose of the test product (T) will be administered (as per the 
randomization schedule) with 240 mL of drinking water at ambient temperature, to 
the subjects sitting in upright posture, under the supervision of the investigator or 
medical officer and/or trained study personnel, including the quality assurance 
auditor(s) or monitors. 
Investigational Medicinal products should not be chewed or crushed and should be 
swallowed whole. 
This activity will be followed by a mouth check with the help of a tongue depressor 
and a torch light to assess compliance to dosing. 
Note: Subjects in each SAD cohort will receive a single oral dose at the following 
planned dose levels: 
SAD Cohort 
Dose Level 
02 capsules 
2 
04 capsules 
3 
06 capsules 
4 
08 capsules 
Note: 
• 
Dosing will be done under yellow monochromatic light condition. 
• 
Dosing will be done individually for each cohort groups (Cohort 01, 
Cohort 02, Cohort 03, Cohort 04). The subsequent group's check-in will 
Tliis documl'llt is strictly cOllfidelltill1 alld it is all illtellectulIl property 0/ Spillos Life Sciellce altd Research Private Limited and SichulIll 
Credit Pharmaceutical Co., Ltd, ChillI!. This should 110t be disclosed to allY third party, with the exceptioll o/regulatory bodies alld study 
audit persollal. Reproductioll, modificlltioll or IIdaptlltioll, ill part or ill total is strictly forbiddell without prior writtell approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 10 of76 
2.7 

Restriction 
--------_._--------------------, 
STUDY PROTOCOL 
Study Protocol No.: 
SLS-BE-O I 45-25-CREN 
Version No: 
01 
Date: 
21 Jan 26 
Single 
ascending dose 
(SAD) 
study with 
Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate 
(L-5-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
be at the check-out day of the previous group to ensure the subject's 
safety. 
during the study 
The subjects will fast for at least 08.00 hours prior to dosing and 04.00 hours post-
dose. 
Blood 
Handling 
Pl'ocedure 
In study period, drinking water will be restricted from at least 01.00 hour prior to 
dosing until 01.00 hours post-dose except 240 mL of drinking water during 
dosing. After 01.00 hours post dose, drinking water will be provided ad libitum. 
Subjects will remain in the sitting position for at least 04.00 hours of post-dose and 
only necessary movement will be allowed during this period. Thereafter, subjects 
will be allO\yed to move freely duri~g the remaining part o[ the study. However, 
they will not be allowed to take part in any kind of strenuous exercise/activity. 
Note: Subjects' diet from at least 48.00 hours pre-dose and at least 72.00 hours post dose 
will be controlled. The meals during the diet control period should be eicosapentaenoic 
acid and folate limited. 
Blood sample will be drawn through an intravenous cannula inserted in a 
Sample 
superficial forearm vein of the subject. The cannula will be kept in situ up to 24.00 
and hours post dose or as per subjects convenience. 
Time Points 
A total of 36 blood samples will be collected in study period (including pre-dose 
sample). The pre-dose (-24.00, -12.00, -01.00, -00.50 and 00.00 hour) blood sample 
08 mL will be collected within 10 minutes prior to dosing. Post dose blood samples 
08 mL will be collected at 00.25, 00.50, 00.75, 01.00, 01.25,01.50,01.75, 02.00, 
02.50, 03.00, 04.00, 05.00, 06.00, 06.50, 07.00, 07.50, 08.00, 08.50, 09.00, 10.00, 
12.00, 16.00, 24.00, 48.00, 72.00 hours respectively (+02 minutes allowed for in 
house). (120.00, 168.00,240.00,312.00,384.00 and 432.00 hours samples will be 
collected on ambulatory basis (±60 minutes)). All samples will be collected in pre-
labeled K2EDT A- vacutainers from a forearm vein using an indwelling cannula as 
per the discretion of the investigator. Heparin-lock technique will be used to 
This documellt is strictly cOl/fidel/tial and it is all il/tellectual property Of Spillos Life Sciellce alld Research Private Limited allll Sichuall 
Credit Pharmaceutical Co., Ltd, Chilla. This shoultf 1I0t be tlisclosed to till)' third party, with the el:ceptioll of regulatory bodies alld study 
audit persollal. Reproductioll, modificatioll or adaptatioll, ill part or ill total is strictly forbidden without prior writtell approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 11 of 76 

Blood Loss 
Sample 
Processing and 
Storage 
STUDY PROTOCOL 
Study Protocol No.: 
SLS-BE-O 14S-2S-CREN 
Version No: 
01 
Date: 
21 Jan 26 
Single 
ascending dose (SAD) 
study with Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate 
(L-S-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
prevent clotting of blood in the indwelling cannula. Before each blood sample is 
drawn via the indwelling cannula, O.S mL of blood will be discarded so as to 
prevent the saline diluted blood and heparin (10 IU/mL) from interfering with the 
analysis. Cannula will be removed after 24.00 hours sample is drawn or earlier if 
blocked. If required, sample may also be collected through a direct vein puncture 
for the 48.00 and 72.00 hours of in-house post dose blood samples and 120.00, 
168.00, 240.00, 312.00, 384.00 and 432.00 hours of ambulatory samples (±60 
minutes). Vacutainers will be placed upright in a rack kept in a wet ice bath until 
centrifugation and during separation. 
Note: Sampling will be done under yellow monochromatic light condition. 
Not exceeding 322 mL (including Screening + in-house + Ambulatory + Post 
study) for the entire study. 
In house samples 
Ambulatory samples 
Total samples 
30 
06 
36 
After the collection of blood samples, the study personnel will place the collected 
samples in a thermo-insulated box containing wet ice and transfer the box to the 
sample processing room, where the blood samples will be centrifuged at 4000 ± SO 
RPM for 10 minutes at 02°C to 08°C to separate the plasma. Centrifugation will 
start within 30 minutes of the collection of samples, at each collection time-point. 
The resulting plasma will be equally transferred into six aliquots, which contain 10 
mg/mL solution of stabilizing agent (solution of 2-mercaptoethanol). 
Aliquot - Oland 02 - Total Eicosapentaenoic Acid (EPA) lipids. 
Aliquot - 03 and 04 - Free (unesterified) Eicosapentaenoic acid (EPA) lipids 
Aliquot - OS and 06 - L-S-methytetrahydrofolate (L-S-MTHF) 
Preparation of stabilisation agent (10 mg/mL solution of 2-mercaptoethanol): 
Measure SO mL of water and transfer into 100 mL reagent bottle, and add 
This docllmellt is strictly cOllfidelltial alld it is all illtellectual property of Spillos Life Sciellce ami Research Private Limited alld Sichuall 
Credit Pharmaceutical Co., Ltd, Chilla. This should 1I0t be disclosed to lilly third party, with the exception of regulatory bodies alld study 
audit persollaL Reproductioll, modificatioll or adaptatioll, ill part or ill total is strictly forbiddell withollt prior writtell approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 12 of76 
27 .JAN ZQ26 

Subject Safety 
Measures 
STUDY PROTOCOL 
Study Protocol No.: 
SLS-BE-014S-2S-CREN 
Version No: 
01 
Date: 
21 Jan 26 
Single 
ascending dose 
(SAD) 
study 
with Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate 
(L-S-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
approximately 1000 mg of 2-mercaptoethanol in water and add SO mL of water mix 
well. Sonicate in ultrasonic bath for few minutes. Provide a suitable batch number 
and complete the 'Solution Preparation Form'. Use this solution for four days from 
the date of preparation. 
From the resulting plasma 1 mL will be transferred into pre-labeled polypropylene 
tubes which containing 10% w/v of Stabilizing agent (add 100 ilL of stabilizing 
agent for 900 ilL Plasma) as aliquot V and aliquot VI respectively. To ensure the 
complete mix up of contents in the RIA vial, vortex completely before storing. 
All the activities performed under Yellow monochromatic light. 
Note: 
• 
As per the requirement, samples will be transferred from Clinical 
Facility to Bio-Analytical Facility even in between of clinical phase. 
• 
Sample processing and segregation will be done under yellow 
monochromatic light. 
• 
Blood pressure, radial pulse rate, body temperature, and wellbeing status 
will be enquired and recorded at pre-dose 00.00 hour (within 7S minutes 
of before dosing) and at 01.00, 03.00, 06.00, 12.00, 24.00, 48.00 and 
60.00 hours (± 60 minutes) post dose. 
• 
Seated blood pressure, radial pulse rate, body temperature, and well-
being status will be assessed and recorded prior to the collection of 
ambulatory blood samples at 120.00, 168.00, 240.00, 312.00, 384.00 
and 432.00 hours from post-dose. 
• 
Physical examination and vitals will be recorded before check-in, check-
out (72.00 hours) for study period and at any time if necessary. 
• 
ECG will be recorded before check out (72.00 hours) for study period 
and if any subject is withdrawn or dropped out during the study. 
• 
Monitoring for adverse events will be done throughout the study period 
This document is strictly confidelltial and it is an intellectual property of Spinos Life Science alld Research Private Limited ami Sichuan 
Credit Pharmaceutical Co., Ltd, China. This should not be disclosed to (lilY third part)', witlt tlte exception of regulatory bodies a1/d study 
audit perso1/al Reproduction, modification or adaptation, i1/ part or i1/ total is strictiy forbidden without prior written approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 13 of 76 
2026 

Screening and 
Post Study 
Parameters 
Bio-analytical 
Procedure 
STUDY PROTOCOL 
Study Protocol No.: 
Version No: 
Date: 
SLS-BE-014S-2S-CREN 
01 
21 Jan 26 
Single ascending dose 
(SAD) 
study with 
Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate 
(L-S-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
in clinical phase. 
For Screening: 
• 
Haematology 
• 
Biochemistry 
• 
Serology 
• 
Urine routine analysis 
• 
12 lead ECG and Chest X-ray 
• 
Serum Pregnancy Test (for females only) 
• 
Hormone assay (FSH) (for females only) 
During Check-in: 
• 
Urine drug of abuse test (Marijuana-THC, amphetamine-AMP, barbiturates-
BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) and 
alcohol test (urine sample) will be done prior to check-in of study period. 
• 
Urine pregnancy test (for females) will be done prior to check-in for study 
period. 
• 
Gynecological and breast examinations (for females) will be done before 
check in of study period only. 
For Post Study Assessment: 
• 
At the end of study period (72.00 hours) or after the subject has withdrawn 
or dropped-out from the study, blood samples will be collected for post 
study laboratory assessments include Haematology and Biochemistry. 
• 
ECG will be recorded before check out for study period or after any subject 
is withdrawn or dropped out from the study (72.00 hours). 
• 
Serum Pregnancy Test (For Female Only). 
Total Eicosapentaenoic Acid (EPA) lipids, Free (unesterified) Eicosapentaenoic 
acid (EPA) lipids and L-S-methyltetrahydrofolate (L-S-MTHF) in plasma will be 
assayed using a validated LC-MS/MS method after completion of each SAD dose 
This document is strictly confidefltial alld it is all illtellectual property of Spillos Life Sciellce alld Research Private Limited alld Sichuall 
Credit Pharmaceutical Co., Ltd, Chilla. This should IIOt be disclosed to o/ly third party, with the exceptioll of regulatory bodies alld study 
audit personal Reproductioll, modificatioll or adaptatioll, ill part or ill total is strictlyforbiddell without prior writtell approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 14 of76 
Z 7 JAN ZOZtl 

Pharmacokinetic 
& Statistical 
Parameters 
STUDY PROTOCOL 
Study Protocol No.: 
SLS-BE-0145-25-CREN 
Version No: 
01 
Date: 
21 Jan 26 
Single 
ascending dose 
(SAD) study with Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate 
(L-5-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
level. 
For Eicosapentaenoic Acid (EPA): Pre-dose blood samples will be drawn at -
24.00, -12.00, 00.00 hours and post dose blood samples will be drawn at 01.00, 
02.00, 03.00, 04.00, 05.00, 06.00, 06.50. 07.00, 07.50, 08.00, 08.50, 09.00, 10.00, 
12.00, 24.00, 48.00, 72.00, 120.00, 168.00, 240.00, 312.00, 384.00 and 432.00 
hours. 
For L-5-MethyItet.-ahydrofolate (L-5-MTHF): Pre-dose blood samples will be 
drawn at -01.00, -00.50, 00.00 hours and post dose blood samples will be drawn at 
00.25,00.50,00.75, 1.00, l.25, 1.50, 1.75,02.00,02.50,03.00,04.00,05.00,06.00, 
08.00, 10.00, 12.00 and 16.00 hours. 
Note: 
• 
Other vitamins and minerals will not be assayed. 
•. Sample analysis will be done under yellow monochromatic light. 
The following pharmacokinetic parameters for Eicosapentaenoic Acid (EPA) and 
Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) will be calculated using non-
compartmental model of Phoenix WinNonlin® version 8.3 or higher version of 
Pharsight Corporation, USA or SAS® software version 9.4 or R software or above 
(SAS Institute Inc., USA) or applicable software. 
1) Total EPA lipids in plasma 
2) Baseline-adjusted total EPA lipids in plasma 
3) Free (un esterified) EPA lipids in plasma 
4) Baseline-adjusted free (unesterified) EPA lipids in plasma 
5) L-5-methytetrahydrofolate 
6) Baseline-adjusted L-5-methytetrahydrofolate 
For non-adjusted Total EPA lipids and Baseline-adjusted total EPA lipids: 
Primary parameters: Cmax and AUCo-72h 
Secondary parameters: Tmax, tv" Kel and AUC_%Extrap_obs AUCo_t and AUCo_o:> 
This documellt is strictly cOllfidelltial ami it is all intellect/wi property of Spinos Life Sciellce a/l(l Research Private L/illiteli alld Sichuan 
Credit Pharmaceutical Co .• Ltd, China. This sltould not be disclosed to any tltird pnrty, witlt tlte exception of regulatory bodies alld study 
audit personal. Reproductioll, modificatioll or adaptation, ill part or in total is strictly forbiddell without prior written approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 15 of 76 
2026 

Statistical 
Analysis for 
Dose linearity/ 
proportionality 
STUDY PROTOCOL 
Study Protocol No.: 
Version No: 
Date: 
SLS-BE-014S-2S-CREN 
01 
21 Jan 26 
Single 
ascending dose 
(SAD) 
study 
with Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate 
(L-S-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
For non-adjusted free (unesterified) EPA lipids and Baseline-adjusted free 
(unesterified) EPA lipids: 
Primary parameters: Cmax and AUCO-72h 
Secondary parameters: Tmax, t'h, Kel and AUC_%Extrap_obs AUCo-t and AUCo_oo 
For non-adjusted L-S-methytetrahydrofolate and Baseline-adjusted L-S-
methytetrahydrofolate: 
Primary parameters: Cmax, AUCo_h and AUCo_oo 
Secondary parameters: Tmax, ty" Kel and AUC_%Extrap_obs 
Note: 
The mean of the pre-dose levels (period specific) should be used for the baseline 
adjustment of the post-dose levels of respective analyte. Baseline concentrations 
. 
. 
. 
will be determined for dosing period, and baseline corrections will be period 
specific. Any negative values obtained from baseline correction should be 
designated as zero (0) prior to calculating the baseline-corrected phannacokinetic 
parameter .. 
Interim PK analyses will be performed after completion of each SAD dose level. 
Summary statistics will be used to describe the PK profile for each dose level. 
Statistical analysis will be performed using SAS® (SAS Institute Inc., USA) 
Version 9.4 or higher for, 
• 
Baseline- adjusted total EPA lipids, 
• 
Baseline- adjusted free (unesterified) EPA lipids. 
• 
Baseline- adjusted L-S-MTHF 
ANOV A Model: 
The dose-normalized pharmacokinetic parameter AUC and Cmax will be analyzed 
using ANOV A. The Rdnm will be the dose-normalized geometric means for 
highest dose relative to lowest dose. 
Dose linearity: 
Dose linearity will be tested by fitting the model: 
Tltis document is strictly cOlljidelllial amI it is {Ill intellectual property of Spinos Life Science allll Research Private Limited and Sichuan 
Credit Pharmaceutical Co., Ltd, Chilla. This should not be disclosed to allY third party, with the exceptioll of regulatory bodies and study 
audit personal. Reproduction, modification or adaptation. in part or in total is strictly forbidden without prior writtell apprOl'al by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 16 of 76 
27 JAN 2026 

Dose Iinearity/ 
proportionality 
criteria 
Ethical Issues 
STUDY PROTOCOL 
Study Protocol No.: 
SLS-BE-0145-25-CREN 
Version No: 
01 
Date: 
21 Jan 26 
Single 
ascending dose (SAD) 
study 
with Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate 
(L-5-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
10g(PK parameter) = a + b*log(dose) + Dose 
Power Model: 
Dose proportionality will be evaluated by assessing the slope from regression 
analysis oflog (AUC or Cmax) versus log (dose) from the power model. 
ANOV A model: The 90% CI for the ratio of dose-normalized (highest to lowest), 
geometric mean values (Rdnm) for In-transformed Cmax and AUC for baseline-
corrected total EPA lipids and baseline-corrected L-5-MTHF should be within 
80.00% to 125.00%. 
Linearity Model: Dose linearity will be concluded if the p- value for the In-
transformed Cmax and AUC for baseline-corrected total EPA lipids and baseline-
corre~ted L-5-MTHF are not ~ignificant (p-value >0.0.5). 
Dose Proportionality: Dose proportionality will be concluded when the 90% CI 
for model-predicted Rdnm (highest to lowest) for Cmax and AUC is contained 
within 80.00% to 125.00%. 
Note: Baseline-corrected free (unesterified) EPA lipids data will be submitted as 
suppoliive evidence of comparable therapeutic outcome. 
The study will commence only after written approval is obtained from the Ethics 
Committee. The study will be conducted as per the National Ethical Guidelines for 
Biomedical and Health Research involving Human participants ICMR (2017), ICH 
E6 (R3) (Step 4) 'Guidance on Good Clinical Practice', New Drugs and Clinical 
Trials Rules 2019 [Gazette notification G.S.R.227 (E), Dated 19.03.2019], India 
and its Amendment Rules [Dated 19th Sep, 2024], 'Good Laboratory Practice', 
'Good Clinical Practices for Clinical Research in India' Guidelines, Good Clinical 
Laboratory Practice (GCLP), Declaration of Helsinki (Finland, October 2024) and 
NMPA ( National Medical Products Administration) regulatory requirements. 
This documellf is strictly confidelltial ami it is all intellectual property of Spinos Life Science and Research Private Limited alld Sichuall 
Credit Pharmaceutical Co., Ltd, Chit/a. This should 1I0t be disclosed to allY third party, with the exceptioll of regulatory bodies lind study 
audit persollal. Reproductioll, modification or adaptation, ill part or in total is strictly forbidden without prior written approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 17 of 76 
Z 7 JAN 2026 

DigiSigner Document ID: 1 f3bb48f-04bd-463d-9a65-bf89331 ff079 
STUDY PROTOCOL 
Study Protocol No.: 
Version No: 
Date: 
SLS-BE-0145-25-CREN 
01 
21 Jan 26 
Single 
ascending 
dose 
(SAD) study with 
Dose Linearity of 
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate 
(L-5-MTHF) following oral administration of different dose levels of 
CreNeuroS® CNS Fish Oil Plus Softgels under fasting condition. 
2. INVESTIGATORS DECLARATION 
We, the undersigned, have read and understood this protocol and hereby agree to conduct 
the study in accordance with this protocol and to comply with all the requirements 
regarding the obligations of investigators and all other pertinent requirements of the 
National Ethical Guidelines For Biomedical and Health Research Involving Human 
Participants ICMR (2017), ICH E6 (R3) (Step 4) 'Guidance on Good Clinical Practice', 
New Drugs and Clinical Trials Rules 2019 [Gazette notification G.S.R.227 (E), Dated 
19.03.2019], India and its Amendment Rules [Dated 19th Sep, 2024], 'Good Laboratory 
Practice', 'Good Clinical Practices for Clinical Research in India' Guidelines, Good 
Clinical Laboratory Practice (GCLP), Declaration of Helsinki (Finland, October 2024) and 
NMPA (Nati.onal Medical Products Administration) regulatory requirements. 
We agree to comply with all relevant SOPs required for the conduct of this study. We 
further agree to ensure that all associates assisting in the conduct of this study are 
informed regarding their obligations. 
Sign and Date w.iUPMiSI 
Name: Dr. Pradeep. T, MBBS, MD., 
Designation: Principal Investigator 
pradeep. t((v'spinoslifescience.com 
J1jalj~ MiJAMi2.1J~~t~~2efesde 
7'41"4?pM 1ST 
Sign and Date 
Name: Mr. Vijaya Krishnan.L, M.Pharm., 
Designation: Bioanalytical Investigator 
vi j ayakrishnan.l@spinoslifescience.com 
Sign and Date 
Name: Ms. Saranya, B.sc (Statistics)., 
Designation: Statistical Investigator 
statistical16@gmail.com 
This documellt is strictly cOllfidelltial alld it is all illtel/ectual property oj Spillos LiJe Sciellce alld Research Private Limited and Siehuall 
Credit Pharmaceutical Co., Ltd, China. Tilis should Ilot be disclosed to allY third party, with the e:'(ceptioll oj regulatory bodies alld study 
audit persollal Reproductioll, modificatioll or adaptatioll, ill part or ill total is strictly forbiddell without prior writtell approval by SLS. 
TEMPLATE-SLS-CL-070-04 
Page 18 of 76 

Audit Trail 
DigiSigner Document ID: 1 f3bb4Sf-04bd-463d-9a65-bfS9331 ff079 
Signer 
Signature 
IP Address: 2401 :4900:629d:Sada:7460:133:ecf5:3663 
IP Address: 103.114.209.191 
IP Address: 2401 :4900:6753:f455:9cSd:5eff:fed5:a313 
Event 
User 
Time 
IP Address 
Upload document 
it@spinoslifescience.com 
21/01/2026 7:13:02PM 1ST 
103.114.209.191 
Open document 
it @ spin~slifescience.com 
21/01/2026 7:13:06PM 1ST 
103.114.209.191 
Close document 
it@spinoslifescience.com 
21/01/2026 7:14:46PM 1ST 
103.114.209.191 
Send for signing 
it@spinoslifescience.com 
21/01/20267:15:01 PM 1ST 
103.114.209.191 
Open document 
unknown 
21/01/2026 7:23:06PM 1ST 
·2401 :4900:629d:8ada:7 460: 1 
33:ecf5:3663 
Sign document 
unknown 
21/01/2026 7:23:10PM 1ST 
2401 :4900:629d:8ada:7460:1 
33:ecf5:3663 
Close document 
unknown 
21/01/20267:23:10PM 1ST 
2401 :4900:629d:8ada:7 460: 1 
33:ecf5:3663 
Open document 
unknown 
21/01/2026 7:43:32PM 1ST 
103.114.209.191 
Sign document 
unknown 
21/01/2026 7:43:42PM 1ST 
103.114.209.191 
Close document 
unknown 
21/01/2026 7:43:42PM 1ST 
103.114.209.191 
Open document 
unknown 
21/01/2026 S:32:04PM 1ST 
103.114.209.191 
Open document 
unknown 
21/01/2026 S:32:43PM 1ST 
2401 :4900:6753:f455:9cSd:5e 
ff:fed5 :a313 
Sign document 
unknown 
21/01/2026 S:32:59PM 1ST 
2401 :4900:6753:f455:9cSd:5e 
ff:fed5:a313 
Close document 
unknown 
21/01/2026 S:32:59PM 1ST 
2401 :4900:6753:f455:9cSd:5e 
ff:fed5:a313 
27 JAN 2026 

'iTt D\ I'IH n 0<01, 
SWd:. Protocol '\0, : 
\nsiofl '0: 
Dale: 
'>1 "Ill .(1) 
.; 
'~ .~ RI '\ 
(1 , , , 
.... ;11 
'c'lld 
dl)'"-.l' 
(',\ I)) 
·,tlld\ 
ttl: 
I), 
I h..,1 "">Jj1i...:iit;,il'lllil\..' \,.Id 
iI ';·,\1 II! I i t;.\I,,\\, 
J, 'iPO'\SOH DFU.AR·\TIO,\ 
II 1'.'\ I :111\! l:lkillill ! 
' .. \1 
dm!,,',bk 
"1',11 
adlllilli~llmi(1I1 ,II' dlll~'r<:111 d,l,C k\\;I, III' 
IluIIlClnl':lrtICIP:lIlh 1<. \1R(20irl.l( 111·.IJ(I{)){Stc'jli)'(,uidalhxl'll 
(illI1it.:illl<:";. (I'H,d l'lilli<:ail:lhllratl)rI !'raLli<:,' ((/('11'1. [kcl:lnllioll uliklsil1ki (I·inland, 
()ctpher 202:11 I!lld 0;)\11),\ ('\atinll',ti \kdi(al Pf(,ducl--; 1\'dJ1lilli.,lraliun ) 
1\:lllllatur~ 
I\:q II i f"Ill<;il1h. 
SigllHturt' Hild datt' 
1\11', lIitcsh Shah 
Din'rlot' 
0pt'rations 
SidlUan ('r{'{lil Phanllareutiral Co .. Ltd. 
Shulljiallg Srl'lioll of \'Vuhou An'lIue, 
Wulloll Dislril'1. Chengdll City, 
Sil'iluan 1'1'0\ jllt'c. China, 
TckphOIll' () nirt: (01';6 )-02S·H5550Hl)O 
., hi .. :/(J,'IIf1f(·1If i\ ,(rio/.l 'i/·,jidr'lIlfIlJ IIl1d If [\ .Iii inld/l't'!II,;J P[(ljh'rfl' til )/If'UU\ I U1' ,)t ir.'l1l·(' ii/II! H{'~t'arl'1I I)ril'!lt~-' I imili'd lIn:! ,\icJttUIII 
("('i!i, PIII!rml}('I"w;' (// ( (/" I.rd. ( hilliL rlti\ .,JfiJliId Itflt hi' lIi.,I'III\\'1I {II run third f'artl', I-dtlllh(' e.\"c('/JlioN (~/ r(!ftil!tfor:l hodie\ (/ltd \!lif!l' 
llU,/it r','f\Olllll N~'prlhh/(·firJf1. /f/orl/~fiulli"J1 or ,(threw/jolt. if! IINr( lit ill (Iillii i\ \/fj"Zl Jorhirldl'1I !1'iriloU( fJrirJr 1\ rll1<.'11 df1I!r(/I'i1IIJi' \"/ S. 
Tn 11'1.\TI·SIS·(I.-W'O·O,j 
27 JAN 2026