| CTRI Number |
CTRI/2024/12/077726 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in normal healthy participants to evaluate the main out come of PK and safety, tolerability after exposure to Biocon’s ustekinumab given as single dose of 45 mg SI either by an autoinjector or by a prefilled syringe in a comparative clinical study. |
|
Scientific Title of Study
|
A phase 1, randomized, open-label, 2-arm, parallel design study in normal Healthy subjects to evaluate pharmacokinetics, safety, and tolerability of Bmab 1200 -autoinjector (biosimilar ustekinumab) after single Subcutaneous injection in comparison with Bmab 1200 -prefilled syringe
(biosimilar ustekinumab)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIO-USTEKI-104, Version:-1.1, 28/06/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDwarkesh Oswal MD |
| Designation |
Principal Investigator |
| Affiliation |
Lambda Therapeutic Research Ltd., |
| Address |
Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak University, S. G. Highway, Gota, Ahmedabad-382481.
Gujarat. India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202281 |
| Fax |
|
| Email |
dwarkeshroswal@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarika S Deodhar |
| Designation |
Sr Director (Medical Lead) |
| Affiliation |
Biocon Biologics Limited |
| Address |
Biocon Biologic Limited, Electronic City, Bangalore, 560100, KARNATAKA, India
Bangalore
KARNATAKA
560100
India |
| Phone |
08028085302 |
| Fax |
|
| Email |
sarika.deodhar@biocon.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayanti Panda |
| Designation |
Sr Director |
| Affiliation |
Biocon Biologics Limited |
| Address |
Biocon Biologic Limited, Electronic City, Bangalore, 560100,KARNATAKA, India
Bangalore
KARNATAKA
560100
India |
| Phone |
08028085304 |
| Fax |
|
| Email |
Jayanti.Panda@biocon.com |
|
|
Source of Monetary or Material Support
|
| Biocon Biologics UK Limited,
16, Great Queen Street, Covent Garden, London, United Kingdom, WC2B 5AH |
|
|
Primary Sponsor
|
| Name |
Biocon Biologics UK Limited |
| Address |
16, Great Queen Street,
Covent Garden, London, WC2B 5AH, United Kingdom
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biocon Biologics Limited |
Biocon Biologics Limited Biocon House, Ground Floor Tower-3, Semicon Park, Electronic City, Phase-ll Hosur Road. Bengaluru, Karnataka- 560100 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dwarkesh Oswal MD |
Lambda Therapeutic Research Ltd. |
Lambda Therapeutic Research Ltd., Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad - 382481, Gujarat, India.
Ahmadabad
GUJARAT |
07940202281
dwarkeshroswal@lambda-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bmab 1200 AI (Biosimilar Ustekinumab) |
Dosage Form: injection, Auto-injector (AI)
Strength(s): 45 mg/ 0.5 mL
Route of Administration: Subcutaneous
Frequency and Dose: 45 mg, single dose
|
| Comparator Agent |
Bmab 1200 PFS (Biosimilar Ustekinumab) |
Dosage Form: injection, Prefilled Syringe (PFS)
Strength(s): 45 mg/ 0.5 mL
Route of Administration: Subcutaneous
Frequency and Dose: 45 mg, single dose
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
a.Non-smokers, healthy, adult, human volunteers between 18 to 55 years of age (both inclusive).
b.Having BMI between 18.5 to 28.0 m2 and having a body weight between 60 kg and 90 kg (both inclusive for bothe parameters).
c.Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
d.Able to understand and comply with the study procedures, in the opinion of the investigator.
e.Able to give voluntary written informed consent for participation in the study.
f.Subjects should not receive a BCG vaccine within 1 year before dosing and agree to not take it during the study and at least 1 year after dosing.
g.Subjects will agree not to receive live vaccination during the study.
h.Subject will agree not to donate blood/ plasma/ platelets during the study and at least 3 months after the end of study.
i.For male subjects
i.Subjects agree to use effective contraception (e.g. Double barrier method) and refrain from donation of sperm from check-in until 90 days after the end of study.
j.In case of female subjects:
i.Surgically sterilized at least 6 months prior to study participation
Or
If subject is of child-bearing potential, is willing to use a suitable and effective double barrier contraceptive method or intrauterine device during the study and till 4 months after the end of study.
Or
Post-menopausal women.
And
ii.Serum pregnancy test must be negative.
iii.Subjects will agree to refrain from donation of ova from check-in until 90 days after the end of study.
|
|
| ExclusionCriteria |
| Details |
a. Known hypersensitivity or idiosyncratic reaction to ustekinumab or any excipients or any related drug or any substance (specifically any biologic product or the constituents of Bmab 1200).
b. Known hypersensitivity to host cell [ murine myeloma cell or Chinese hamster ovary cells] derived proteins, latex), food, or other substance.
c. 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.
d. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes,
e. Use or intend to use any prescription medications/products or other acceptable concomitant Medications within 30 days prior to dosing or slow-release medications/products considered to still be active within 14 days prior to check-in.
f. Use or intend to use any nonprescription medications/ products, including vitamins, minerals, and phytotherapeutic/ herbal/ plant-derived preparations within 7 days prior to check-in.
g. Use of any vaccine from 4 weeks prior to screening;
h. The QTc interval more than 450 ms for male and more than 460 ms for female at the time of screening.
i. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.
j. A recent history of harmful use of alcohol (less than 2 years), or consumption of alcohol or alcoholic products within 48 hours prior to receiving study drug.
k. Smokers, or who have smoked within the last six months prior to the start of the study.
l. The presence of clinically significant abnormal laboratory values during screening.
m. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
n. History or presence of seizure or psychiatric disorders.
o. A history of difficulty with donating blood.
p. Donation of blood (1 unit or 350 mL) or plasma/ platelets in the last 90 days prior to screening until 3 months after the end of study visit.
q. Participation m a clinical study involving the administration of an investigational drug in the past 90 days or 5 half-lives (whichever is longer), prior to dosing.
r. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
s. A positive test result for HIV antibody (I &/or 2).
t. Current history of active infections, including significant localized infections, cough or fever, or current /previous history of recurrent or chronic infections. (At screening and within 1 week prior to study drug administration)
u. History of active tuberculosis (TB) or presence of active or latent TB. A positive result for IGRA (Interferon Gamma Release Assay) test at screening.
v. Known history of previous exposure to ustekinumab or ustekinumab biosimilar, or any IL-12 or IL-23 monoclonal antibodies, approved or investigational.
w. Consumption of grapefruit or grapefruit products within 72 hours prior to dosing.
x. An unusual diet, for whatever reason (for example, fasting, high potassium or low sodium), for four weeks prior to receiving the study medicine. In any such case, subject selection will be at the discretion of the Principal Investigator.
y. Ingestion of poppy seed-containing foods or beverages within 7 days prior to check-in.
z. Receipt of blood products within 2 months prior to check-in.
aa. Poor peripheral venous access.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| o Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf) and maximum observed concentration (Cmax) of drug Bmab 1200 given as single dose of 45 mg subcutaneously either by an autoinjector (AI) or by a prefilled syringe (PFS) |
Week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AUCo-t (Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification ) |
Week 16 |
| Tmax(time to maximum observed concentration) |
Week 16 |
| AUC_%Extrap_obs (% of the AUC that has been derived after extrapolation.) |
Week 16 |
| ƛz – Elimination rate constant |
Week 16 |
| Vd (Volume of distribution) |
Week 16 |
| Cl (drug clearance) |
Week 16 |
| t1/2 (apparent terminal elimination half-life) |
Week 16 |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
Final Enrollment numbers achieved (Total)= "186"
Final Enrollment numbers achieved (India)="186" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| Date of Study Completion (India) |
22/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Bmab 1200 is being developed as a proposed biosimilar product to the
reference product Stelara® in accordance with EU and US biosimilar guidelines.
The currently available Bmab 1200 formulation is administered via SC injection
using PFS (similar to the reference product Stelara®). The main purpose of this
study is to establish the PK equivalence of Bmab 1200 -AI following a single SC
injection ( 45 mg) in comparison with Bmab 1200 -PFS. AI and PFS are
self-injectable devices that can deliver drugs through the SC route. This study
will also assess the safety and tolerability of Bmab 1200 AI in comparison with
Bmab 1200 PFS. This will enable the licensure of AI to improve patient
compliance through controlled and standardized administration of Bmab 1200 |