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CTRI Number  CTRI/2024/05/068025 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the pharmacokinetics of the test product recombinant asparaginase with the reference product Spectrila® in healthy, adult, subjects. 
Scientific Title of Study   A double blinded, balanced, randomized, single dose, parallel group, active-controlled study to compare the pharmacokinetics of the test product GBL19 (recombinant asparaginase, Gennova Biopharmaceuticals Ltd.) with the reference product Spectrila® (Medac GmbH) at 5000 IU/m2, in healthy, adult, subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PR/BE/23/281 Version Number 01 Dated 01 Feb 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyesh Katara 
Designation  Clinical Incharge 
Affiliation  Citus Research LLP 
Address  Citus Research LLP 401 406 to 408 Supermall-2 Infocity Campus Near GH Zero Circle Infocity Gandhinagar

Gandhinagar
GUJARAT
382009
India 
Phone  917966542000  
Fax    
Email  priyesh.katara@citusresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Saraf  
Designation  Deputy General Manager 
Affiliation  Gennova Biopharmaceuticals Limited 
Address  Block 1 Plot No P-1 and P-2 ITBT Park Phase II MIDC Hinjawadi Pune India

Pune
MAHARASHTRA
411057
India 
Phone  02039166300  
Fax    
Email  amit.saraf@gennova.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Amit Saraf  
Designation  Deputy General Manager 
Affiliation  Gennova Biopharmaceuticals Limited 
Address  Block 1 Plot No P-1 and P-2 ITBT Park Phase II MIDC Hinjawadi Pune India

Pune
MAHARASHTRA
411057
India 
Phone  02039166300  
Fax    
Email  amit.saraf@gennova.co.in  
 
Source of Monetary or Material Support  
Gennova Biopharmaceuticals Limited Block 1 Plot No P-1 and P-2 ITBT Park Phase-II MIDC Hinjawadi Pune- 411057 
 
Primary Sponsor  
Name  Gennova Biopharmaceuticals Limited 
Address  Block 1 Plot No P-1 and P-2 ITBT Park Phase-II MIDC Hinjawadi Pune 411057  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Priyesh Katara  Citus Research LLP   Clinical department,3rd and 4th floor,CPU unit,Clinical Facility Citus Research LLP,336 to 342, 401, 406 to 408,Supermall-2, Infocity Campus,Near GH Zero Circle,Infocity,Gandhinagar-382 009 Gujarat, India
Gandhinagar
GUJARAT 		 917966542000

priyesh.katara@citusresearch.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  Acute Lymphoblastic leukemia  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GBL19  Lyophilized recombinant L-asparaginase-II for Injection 10000 IU /vial (Dose: 5000IU/m2), intravenously single dose (as an infusion). 
Comparator Agent  Spectrila®   (Recombinant Asparaginase) 10000 IU powder for concentrate for solution for infusion (Dose: 5000IU/m2), intravenously single dose. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Willing to provide written informed consent for participation in the study, and able to comprehend the nature and purpose of the study.2.Willing to be available for the entire study period and to comply with the protocol requirements.3.Normal, healthy, adult, human subject of 20-45 years (both inclusive) of age.4.Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive) with minimum of 50 kg weight.5.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in.6.Normal or clinically non-significant laboratory values as determined by haematological, biochemistry tests (serum ALP, serum creatinine, SGOT/AST, SGPT/ALT, serum uric acid; serum bilirubin–total, direct and indirect; total proteins, serum albumin, serum blood urea nitrogen, triglycerides, cholesterol-total, random blood glucose, aPTT, PT, serum amylase, serum lipase) and urine analysis.7.Normal or clinically non-significant 12-lead ECG recording.8.Non-smokers or subjects who have no history of smoking for the last one year prior to check-in.9.Subjects who are willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in and throughout the study.10.Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to check-in until last sample collection.11.Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) and flavonoid containing products at least 48.00 hours prior to check-in until last sample collection.12.Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection.13.For male subjects:
Subjects willing to use adequate contraception during sexual intercourse with female partners of childbearing potential during the study and for a period of 3 months after receiving last dose of IP.14.For female subjects:Negative urine pregnancy test during screening and negative serum hCG test at the time of check-in.Female subjects with childbearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use acceptable birth control methods for at least 15 days before check-in till 3 months post last-dose. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)]. 
 
ExclusionCriteria 
Details  1.Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs.
2.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), haematological, gastrointestinal, dermatological, immunological, or psychiatric diseases, or organ dysfunction.
3.Any major illness or hospitalized within 90 days prior to check-in.
4.Requiring medication for any ailment having enzyme-modifying activity within one month prior to check-in and throughout the study.
5.Use of any depot injection or an implant of any drug within 3 months prior to check-in and throughout the study.
6.Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to check-in and throughout the study; history or presence of significant gastric and/or duodenal ulceration.
7.Consumption of St John’s Wort within 14 days prior to check in and throughout the study.
8.Suffering from pancreatitis (inflammation of the pancreas).
9.Pre-existing known coagulopathy.
10.Difficulty in swallowing tablets or capsules.
11.Use of any recreational drug or history of drug addiction.
12.Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 180 days prior to check-in.
13.Positive urine alcohol and urine drug of abuse tests during check-in.
14.Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
15.Lactating or nursing female subjects.
16.Female subjects using hormonal contraceptive (oral/implants).
17.History of allergy or hypersensitivity intolerance to asparaginase or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study.
18.History of difficulty in accessibility of veins in arms.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Comparison of area under serum asparaginase activity (SAA) vs. time curves(AUC0-inf) for a single dose of the test and the reference product.

2. Comparison of Cmax of SAA between the test and the reference group. 		 1. Pre-dose (within 2.00 hours before dosing), 0.00 (immediately after infusion), 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hours post-dose.

2. Pre-dose (within 2.00 hours before dosing),0.00 (immediately after infusion), 0.50, 1.00, 1.50,2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hours post-dose. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Area under SAA vs. time curves (AUC0-t).



2. Time to maximum SAA (Tmax).



3. Apparent first-order terminal elimination rate constant (Kel).

4. Total serum clearance (CL).

5. Volume of distribution (Vd).

6.Percent ratio of AUC0-t & AUC0-inf (AUC%Ratio).

7. Percentage area extrapolated from last measurable time point to infinity (AUC% Extrapolated). 		 1. Pre-dose (within 2.00 hours before dosing), 0.00 (immediately after infusion), 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 & 96.00 hours post-dose.

2. Pre-dose (within 2.00 hours before dosing), 0.00 (immediately after infusion), 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 & 96.00 hours post-dose.

3. Upto 96 hours

4. Upto 96 hours

5. Upto 96 hours

6. Upto 96 hours

7. Upto 96 hours 

Depletion of mean asparagine levels in plasma. 
From pre-dose to 96 hours post-dose. 

1. Incidence of adverse events after administration of the test & the reference product.

2. A safety assessment will be done. 
1. Throughout the study (30 days).

2. Day 4, Day 14 & Day 30. 

Anti-drug antibodies (ADA). 
Pre-dose, Day 14 & Day 30. 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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   Phase 1 
Date of First Enrollment (India)   25/06/2024 
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="30" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjay.singh@gennova.co.in].

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 31-08-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This clinical trial is a double-blinded, balanced, randomized, single-dose, parallel-group, active-controlled study to compare the pharmacokinetics of the test product GBL19 (recombinant asparaginase) with the reference product Spectrila® at 5000 IU/m2, in healthy, adult, subjects. The study will enroll 82 healthy participants. Subjects will be housed in the clinical facility unit a day before dosing. The sample will be collected at prespecified time points. Subjects will be under supervision for 96 hours in the CPU unit and subject vital and physical examination, and measurements (blood pressure, pulse rate, body temperature, and respiratory rate) will be monitored at defined periods. Safety laboratory parameters will be assessed on day 4, day 14 & day 30.

 
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