| CTRI Number |
CTRI/2024/09/073894 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate to compare the pharmacokinetic, pharmacodynamics, safety and immunogenicity for three formulations of Tocilizumab |
|
Scientific Title of Study
|
A randomized phase 1, double-blind, single dose, three-arm, parallel group comparative
Pharmacokinetic, Pharmacodynamic, safety, and immunogenicity assessment of BP08 (Tocilizumab) versus US licensed Actemra® and EU approved RoActemra® administration through the Intravenous infusion route in healthy adult male subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 23-VIN-0347 Version No. 01 dated 16 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshankumar Kharadi |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Ltd |
| Address |
Veeda Clinical Research Ltd.
1st, 2nd, 3rd and 4th Floor, VEDANT Complex, Nr. Y.M.C.A. Club, S. G. Highway Road, Vejalpur, Ahmedabad 380 051, Gujarat, India
Ahmadabad
GUJARAT
380051
India |
| Phone |
7967773000 |
| Fax |
|
| Email |
Darshankumar.K3015@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpitkumar Prajapati |
| Designation |
General Manager |
| Affiliation |
CuraTeQ Biologics Private Ltd |
| Address |
CuraTeQ Biologics Private Ltd. Galaxy Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City . Hyderabad, Telangana India 500 081
Hyderabad
TELANGANA
500081
India |
| Phone |
8455255222 |
| Fax |
|
| Email |
arpitkumar.Prajapati@curateqbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpitkumar Prajapati |
| Designation |
General Manager |
| Affiliation |
CuraTeQ Biologics Private Ltd |
| Address |
CuraTeQ Biologics Private Ltd. Galaxy Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City . Hyderabad, Telangana India 500 081
Hyderabad
TELANGANA
500081
India |
| Phone |
8455255222 |
| Fax |
|
| Email |
arpitkumar.Prajapati@curateqbio.com |
|
|
Source of Monetary or Material Support
|
| CuraTeQ Biologics Private Limited, Galaxy Floors: 22-24, Plot No. 1, Survey No: 83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad-500032,Telangana, India |
|
|
Primary Sponsor
|
| Name |
CuraTeQ Biologics Private Ltd. |
| Address |
Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India, 500081 |
| 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 Darshankumar Kharadi |
Veeda Clinical Research Ltd. |
1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club, S.G.Highway Road, Vejalpur, Ahmedabad 380 051, Gujarat, India
Ahmadabad
GUJARAT |
7967773000
Darshankumar.K3015@veedacr.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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult male subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ACTEMRA® (Tocilizumab) |
400 mg (20 mg/mL) injection,
Duration: Single Dose Intravenous infusion of 4
mg/kg in 60 minutes |
| Intervention |
BP08 (Tocilizumab) |
400 mg (20 mg/mL) injection,
Duration: Single Dose Intravenous infusion of 4
mg/kg in 60 minutes |
| Comparator Agent |
RoActemra®(Tocilizumab) |
400 mg (20 mg/mL) concentrate for solution for infusion,
Duration: Single Dose Intravenous infusion of 4
mg/kg in 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Healthy, adult, male human subjects aged between 18 and 45 years (both
inclusive) at the time of signing informed consent.
2. Capable and willing to providing written informed consent to the study
requirements.
3. Have systolic blood pressure ≤140 and ≥90 mmHg, diastolic blood pressure ≤90 and ≥60 mmHg, and a heart rate ≥50 and ≤100 beats per minute at Screening/Day 1 (admission to study center).
4. Subjects with no clinically relevant abnormalities detected during baseline
history, physical examination and vital signs (blood pressure, radial pulse rate,
body temperature, including respiratory rate) as judged by the Investigator.
5. Subjects who are considered healthy as determined by clinically acceptable
findings of haematology, biochemistry, coagulation tests, urinalysis, 12-lead ECG, and echocardiogram.
6. Subjects must refrain from donating sperm or fathering a child during the study and until 9 months after infusion by agreeing to use (with their female partner) 2 acceptable contraceptives.
7. Willing to stay on study restrictions throughout the study duration.
8. A non-smoker or non-alcoholics.
9. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
10. Subjects having negative alcohol breath test/Urine Alcohol test.
|
|
| ExclusionCriteria |
| Details |
1. Known history of hypersensitivity or allergic reactions to Tocilizumab or any of its excipients and heparin.
2. History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological,psychiatric or any other disease which in the opinion of the Investigator would
make the subject inappropriate for study participation.
3. Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
4. Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
5. Use of prescription or non-prescription (OTC) drugs, including vitamins, herbal and dietary supplements (including St. John’s Wort, grapefruit) within 30 days prior to the dosing of study treatment, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety.
6. Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
7. Difficulty in blood sampling or difficulty in the accessibility of veins.
8. Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator and/or a positive test result in breath/urine alcohol done before check-in.
9. Subjects with a history of drug of abuse or positive in urine screen for drug of abuse test at screening or admission.
10. Blood donation within 90 days prior to the commencement of the study and during the study.
11. Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcoholic products within 48 hours prior to admission.
12. Consumption of grapefruit, grapefruit juices within 72.00 hours prior to admission.
13. Any persons who are:
An employee of the Principal Investigator, clinical center, contract research
organization (CRO) or Sponsor.
A relative of an employee of the clinical center, the Investigators, CRO, or the Sponsor.
14. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
15. Intolerance to direct vein puncture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetics : Cmax and AUC0-inf |
Various timepoints from day 1 to day 50 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pharmacokinetic endpoints : AUC0-t, Tmax, t½, ƛz, & CL
|
Various timepoints from day 1 to day 50 |
| Pharmacodynamic endpoints : IL6 levels |
Various timepoints from day 1 to day 50 |
| Immunogenicity endpoints : Anti-drug antibody, & neutralizing antibody to BP08 (Tocilizumab) , US licensed -Actemra® & EU-approved RoActemra |
Various timepoints from day 1 to day 50 |
| Safety endpoints: Adverse events, clinical laboratory values, vital signs, physical examinations, & ECG |
Throughout study duration |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Tocilizumab is a recombinant
humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the
immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide
structure. BP08 is being developed by Cura
TeQ Biologics Private Limited as a Tocilizumab biosimilar to the US licensed
-Actemra® and European Union (EU)-approved RoActemra® and it used for the
following indications. Rheumatoid Arthritis (RA) Giant Cell Arteritis (GCA) Polyarticular Juvenile Idiopathic
Arthritis (PJIA) Systemic Juvenile Idiopathic Arthritis
(SJIA) Cytokine Release Syndrome (CRS)
This study is aimed to compare
the pharmacokinetics (PK) of BP08 with EU-approved RoActemra® and US licensed
Actemra® in healthy male adult subjects using randomized phase 1, double blind,
single dose, three-arm, parallel, comparative assessment of PK, PD safety, and
immunogenicity of BP08 (Tocilizumab) versus US licensed Actemra® and EU
approved-RoActemra® in healthy male subjects. |