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CTRI Number  CTRI/2025/01/078921 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Other 
Public Title of Study   A Study to Evaluate the Safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO)  
Scientific Title of Study   A randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No.: C1B02794 Version: 03 Date: September 19, 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Minesh Patel 
Designation  General Manager  
Affiliation  Cliantha Research Limited 
Address  Cliantha Corporate,TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210,Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  2717698500  
Fax    
Email  mnpatel1@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Singhal 
Designation  Director 
Affiliation  Cliantha Research Limited 
Address  Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  2717698500  
Fax    
Email  msinghal@cliantha.com   
 
Details of Contact Person
Public Query  
Name  Dr Minesh Patel 
Designation  General Manager  
Affiliation  Cliantha Research Limited 
Address  Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  2717698500  
Fax    
Email  mnpatel1@cliantha.com  
 
Source of Monetary or Material Support  
Incepta Pharmaceuticals Ltd., 40, Shahid Tajuddin Ahmed Sarani Tejgaon I/A, Dhaka 1208, Bangladesh.  
 
Primary Sponsor  
Name  Incepta Pharmaceuticals Ltd. 
Address  Tejgaon I/A, Dhaka 1208, Bangladesh. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Cliantha Research Limited  Cliantha Corporate,TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210,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 Minesh Patel  Cliantha Research Limited  Cliantha Corporate,Room number 01 TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad
GUJARAT 		 2717698500

mnpatel1@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sangini Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) 100 micrograms/0.3 ml solution for injection   A single dose (100 mcg) of Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera) will be administered to the subjects slowly by subcutaneous route  
Intervention  Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO)   A single dose (100 mcg) of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) will be administered to the subjects slowly by subcutaneous route 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
1) Age: 18 to 55 years old, both inclusive.
2) Gender: Male and/or non-pregnant, non-lactating female.
A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin pregnancy test performed within 28 days prior to dosing day. They must be using an acceptable form of contraception.
B. For female of childbearing potential, acceptable forms of contraception include the following:
B. For female of childbearing potential, acceptable forms of contraception include the following:
i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
iii. Surgical sterilization or
iv. Practicing sexual abstinence throughout the course of the study.
C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level grater than 40 mIU/mL, or
iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iv. Total hysterectomy and an absence of bleeding for at least 3 months.
3) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
4) Volunteers having body weight not < 50 kg or > 90 kg.
5) Able to communicate effectively with study personnel.
6) Willing to provide written informed consent to participate in the study.
7) Hemoglobin should be between 11-14 g/dl, HCT, Platelet count, ferritin and reticulocyte count percentage should not be higher than the upper limit of normal range.
8) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of study medication administration which will include:
a) A physical examination (clinical examination) with no clinically significant finding.
b) Results within normal limits or clinically non-significant
• Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
• All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
 
 
ExclusionCriteria 
Details  Volunteers must not be enrolled in the study if they meet any one of the following criteria:
1) History of allergic responses to Pegylated Erythropoietin or other related drugs, or any of its formulation ingredients.
2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, endocrine, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
4) History or presence of bronchial asthma.
5) Use of any hormone replacement therapy within 3 months prior to study medication administration.
6) Use of any depot injection or implant of any drug within 3 months prior to study medication administration.
7) Use of CYP enzyme inhibitors or inducers within 30 days prior to study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9) Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
10) History of difficulty with donating blood or difficulty in accessibility of veins.
11) A positive hepatitis screen (includes subtypes B and C).
12) A positive test result for HIV antibody.
13) Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to study medication administration.
14) Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or gather than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to study medication administration, whichever is greater.
15) Intolerance to venipuncture
16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study.
17) Institutionalized volunteers.
18) Use of any prescribed medications within 14 days prior to study medication administration.
19) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to study medication administration.
20) Use of grapefruit and grapefruit containing products within 7 days prior to study medication administration.
21) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to study medication administration.
22) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to study medication administration.
23) Acute bleeding and blood transfusion within 2 months before inclusion in the study.
24) History of chronic bleeding.
25) History of allergies (anaphylactic shock or multiple drug allergy syndrome).
26) Major surgery within 30 days prior to screening, or surgery being scheduled for any time during the study.
27) Diseases or other conditions that can interfere with the pharmacokinetics of the investigational drug (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others).


 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate the pharmacokinetics of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera)  7 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess pharmacodynamics, the safety and tolerability and immunogenicity of the investigational products of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera)

 		 7 weeks 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   21/01/2025 
Date of Study Completion (India) 25/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
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 randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects.

Objectives:

 To compare and evaluate the pharmacokinetics & pharmacodynamic of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera) administered through subcutaneous route in healthy adult human subjects.

      To assess the safety and tolerability of the investigational products.

To assess the immunogenicity of the investigational products. 
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