| CTRI Number |
CTRI/2024/02/063101 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A single dose study to Compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab and Prolia® in pre-filled syringe in healthy adult male subjects. |
|
Scientific Title of Study
|
Single dose study to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia® (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C1B03215 Version 02 Dated 11 Dec 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharit Shah |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha research |
| Address |
Cliantha Research limited Dream Arcadia Opp Mayfair Atrium Vadsar Kalali Road
Vadodara
GUJARAT
390012
India |
| Phone |
919825918974 |
| Fax |
|
| Email |
dharitshah64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Ankola |
| Designation |
Associate Director |
| Affiliation |
Lupin Limited |
| Address |
1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi
Pune
MAHARASHTRA
412115
India |
| Phone |
919930040128 |
| Fax |
|
| Email |
dhawalankola@lupin.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Khandare |
| Designation |
Vice President |
| Affiliation |
Lupin Limited |
| Address |
1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi
Pune
MAHARASHTRA
412115
India |
| Phone |
919833606967 |
| Fax |
|
| Email |
suhaskhandave@lupin.com |
|
|
Source of Monetary or Material Support
|
| Lupin Limited (Biotech limited) Gat No. 1156,1157,1158. 1159 and 1160 |
|
|
Primary Sponsor
|
| Name |
Lupin Limited (Research Park) |
| Address |
46A/47A, Village Nande, Taluka Mulshi, Pune. Pin: 412 115, Maharashtra, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Dharit Shah |
Cliantha Research |
Cliantha Research limited Dream Arcadia Opp Mayfair Atrium Vadsar Kalali Road
Vadodara
GUJARAT |
9825918974
dharitshah64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics Committee Anand Multispeciality Hospital B Tower Sundarvan Complex Beside IOCL Petrol Pump Near Gorwa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult male subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator: Prolia® |
Comparative Pharmacokinetics and Pharmacodynamics study
Denosumab 60 mg solution for injection (60 mg/mL) in pre-filled syringe |
| Intervention |
Lupins Denosumab |
Denosumab 60 mg solution for injection (60 mg/mL) in pre-filled syringe.
Total treatment duration would be 128 days with single dose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
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)
Able to communicate effectively with study personnel.
Willing to provide written informed consent to participate in the study.
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
the first dose of study medication which will include:
a) A physical examination (clinical examination) with no clinically significant finding.
b) Results within normal limits or clinically non-significant for the following tests:
1. Hematology test
2. Biochemistry test
3. Urinalysis
4. Immunological Tests
5. Additional tests
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 Denosumab 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, chest X-ray recording, Ankle Brachial Index test].
3) Any disease or condition like diabetes, psychosis or others, which might compromise
the haemopoietic, 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/e-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 & C).
12) A positive test result for HIV antibody. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparitive pharmacokinetic and pharmacodynamic |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Presence of anti-drug antibodies (ADA) and the neutralizing antibodies
(NAb) will be determined. |
3,6,9,12 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
09/04/2024 |
| 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="4"
Days="8" |
|
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
|
Single dose study to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia® (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects. Study duration 128 days. A double blind, randomized, single-period, two-treatment, parallel, balanced, single dose comparative pharmacodynamic, pharmacokinetic and immunogenicity study. |