CTRI/2025/12/099591 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On:
20/12/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
This is a comparative bioavailability of INTP5 (Pegfilgrastim) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects.
Scientific Title of Study
A Randomized, Balalnced, Open-label, Two-treatment, Two-period,Two sequence, Single dose, Crossover, Comparative bioavailability study of INTP5 Pegfilgrastim of Intas Pharmaceuticals Limited, India when delivered automatically from the on body injector (OBI) delivery device (test product) versus INTP5 (ENNUMOTM) PFS, when delivered manually from a pre-filled syringe (reference product) in normal, healthy, adult, human subjects.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Project No: 0156-22, Version No: 1.0, Dated: 11 October 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shrikrishna Kolte
Designation
General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota Ahmadabad, GUJARAT 382481, India
Ahmadabad GUJARAT 382481 India
Phone
07940202260
Fax
07940202021
Email
shrikrishnaskolte@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota Ahmadabad, GUJARAT 382481, India
Ahmadabad GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota Ahmadabad, GUJARAT 382481, India
GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd,
Corporate House,
Nr. Sola Bridge, S. G. Highway, Thaltej
Ahmedabad - 380054, Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
Corporate House, Nr. Sola Bridge, S. G. Highway, Thaltej Ahmedabad - 380054, Gujarat, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Intas Pharmaceuticals Ltd
Corporate House, Nr. Sola Bridge, S. G. Highway, Thaltej Ahmedabad - 380054, Gujarat, 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 Shrikrishna Kolte
Lambda Therapeutic Research Ltd
Lambda house, Plot
No. 38, Survey no.
388,Near Silver Oak
Club, S. G. Highway,
Gota, Ahmadabad,
GUJARAT
Ahmadabad
GUJARAT Ahmadabad GUJARAT
07940202260
shrikrishnaskolte@lambda-cro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Riddhi Medical nursing Home IEC
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy human subjects
Intervention / Comparator Agent
Type
Name
Details
Intervention
INTP5 (ENNUMOTM) delivered automatically through On Body Injector
(OBI)
Active content: Pegfilgrastim Dose for administration: 6 mg per 0.6 ml Pharmaceutical form: On Body Injector (OBI)
Route of administration: Subcutaneous administered through OBI delivery
device
Comparator Agent
INTP5 (ENNUMOTM) PFS
Active content: Pegfilgrastim
Dose for administration: 6 mg per 0.6 ml
Pharmaceutical form: Pre-filled syringe
Route of administration: Subcutaneous administered manually from a prefilled
syringe
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1) Non-smoking, normal, healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).
2) Having body weight greater than or equal to 50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive),
calculated as weight in kg per height in meter2.
3) Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG, Xray chest (P A view; within the last 6 months) and abdominal ultrasonography recordings.
4) Able to understand and comply with the study procedures, in the opinion of the investigator.
5) Able to give voluntary written informed consent for participation in the trial.
6) In case of female subjects:
a) Surgically sterilized at least 6 months prior to study participation; Or If a woman of child bearing potential is willing to use a suitable and effective double barrier
contraceptive method or intra uterine device during the study.
b) Serum pregnancy test must be negative
ExclusionCriteria
Details
1) Known hypersensitivity or idiosyncratic reaction to the study drug or its constituents and or hypersensitivity to E. coli-derived proteins, and or previous exposure to the study drug
2) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
3) No medication [prescribed & over the counter (OTC) medication] other than the IMP shall be consumed by the subjects from 1 month prior to check-in of period-I. Other than paracetamol or NSAIDs for pain and vitamins, minerals and nutritional supplements that may be taken at the discretion of the Investigator and any vaccine (including COVID-19 vaccine) from 14 days prior to check-in of period-I. In any such case subject selection will be at the discretion of the Principal Investigator designee.
4) Known case of hereditary fructose intolerance
5) Subjects with latex allergies will be excluded as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex).
6) Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin
level at the time of screening.
7) Consumption or use of any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or Pegfilgrastim, immunoglobulin preparations, or immunomodulator’s within the past 6 months Prior to dosing of period-I.
8) Historical evidence of E coli diarrhea or diseases within 3 months.
9) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDsinduced urticaria.
10) Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
11) History of any hematologic disease including sickle cell disorders.
12) Smokers, or who have smoked within last six months prior to start of the study.
13) Receipt of over-the-counter medicines which have not yet cleared from the body (5 half-lives must have passed for the medicine to be considered to have cleared from the body).
14) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women
(A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percentage distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 72 hours prior to check-in of period-I.
15) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug
scans.
16) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study
medication.
17) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
18) A positive hepatitis screen including hepatitis B surface antigen and or HCV antibodies.
19) A positive test result for HIV (1 and or 2) antibody.
20) History or presence of seizure or psychiatric disorders.
21) Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or
inflammation at the proposed site of injection.
22) An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to check-in of period-I. In any such case, subject selection will be at the discretion of the Principal Investigator.
23) Consumption of grape fruit or grape fruit products within 72 hours prior to check-in of period-I.
24) A history of difficulty in donating blood.
25) Females, pregnant or lactating, or planning to become pregnant during the course of the study or
found positive in pregnancy test at screening.
26) Any infections in the last 4 weeks prior to dose administration of period-I.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess comparative bioavailability of INTP5 (Pegfilgrastim) (Delivered automatically from the
on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult,
human subjects.
Time points for OBI:
1) 0.000 (Pre-dose) (Collected within 60 minutes prior to start of drug delivery)
2) At 1, 10, 20 and 30 min After the start of drug delivery
3) Approx. 40 min (i.e. at the end of drug delivery) (Reference timepoint for post-dose sampling timepoints)
4) From end of drug delivery at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, 168.000, 216.000, 264.000, 312.000 hours post-dose.
1) To assess and compare other pharmacokinetic parameters, safety and
tolerability of INTP5 (Pegfilgrastim) (delivered automatically from the on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects.
2) To monitor the performance of on-body injector delivery device in normal, healthy, adult, human subjects
Time points for OBI:
1) 0.000 (Pre-dose) (Collected within 60 minutes prior to start of drug delivery)
2) At 1, 10, 20 and 30 min After the start of drug delivery
3) Approx. 40 min (i.e. at the end of drug delivery) (Reference timepoint for post-dose sampling timepoints)
4) From end of drug delivery at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, 168.000, 216.000, 264.000, 312.000 hours post-dose.
Total Sample Size="134" Sample Size from India="134" 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)
31/12/2025
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="1" Days="14"
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
Primary objective: To assess comparative bioavailability of INTP5 (Pegfilgrastim) (delivered automatically from the on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects.
Secondary objectives: To assess and compare other pharmacokinetic parameters, safety and tolerability of INTP5 (Pegfilgrastim) (delivered automatically from the on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects and to monitor the performance of on-body injector delivery device in normal, healthy, adult, human subjects (as per annex-I).