CTRI/2025/08/092337 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On:
04/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study to compare how DRL_AB is absorbed, modified and removed from the body when administered via autoinjector or pre-filled syringe in normal healthy male participants
Scientific Title of Study
A single-dose, randomized, open-label, parallel-group, comparative pharmacokinetic and safety study of subcutaneously administered abatacept biosimilar DRL_AB via autoinjector or pre-filled syringe in normal healthy male participants
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
AB-01-007, Version 1.0 dated 13 Feb 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Siddangouda Patil
Designation
Senior Manager
Affiliation
Syngene International Limited
Address
Tower I, Semicon Park, Electronic City Phase II, Hosur Road,
Bangalore KARNATAKA 560100 India
Phone
8066332823
Fax
80-6633-2722
Email
siddangouda.patil@syngeneintl.com
Details of Contact Person Scientific Query
Name
Dr Narendra Maharaj
Designation
Head- Clinical Development
Affiliation
Dr Reddy’s Laboratories Ltd
Address
Dr. Reddy’s Laboratories Ltd. Biologics Survey No.47 and 44(PART), Bachupally Village, Bachupally Mandal, Medchal Malkajgiri District, Medchal
Medchal TELANGANA 500090 India
Phone
914044644000
Fax
914023041418
Email
narendramaharaj@drreddys.com
Details of Contact Person Public Query
Name
Naveen Reddy
Designation
Head – Clinical Program Delivery
Affiliation
Dr Reddy’s Laboratories Ltd
Address
Dr. Reddys Laboratories Ltd. Biologics Survey No.47 and 44(PART), Bachupally Village, Bachupally Mandal, Medchal Malkajgiri District, Medchal
Medchal TELANGANA 500090 India
Phone
914044644000
Fax
91402304141
Email
naveenreddy@drreddys.com
Source of Monetary or Material Support
Dr. Reddy’s Laboratories Ltd., Registered office at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana – 500034, India
Primary Sponsor
Name
Syngene International Limited
Address
Syngene International Limited,
Tower I, Semicon Park, Electronic City Phase II, Hosur Road, Bangalore - 560 100, India.
Type of Sponsor
Contract research organization
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 Siddangouda Patil
Syngene International Limited
Tower I, Semicon Park, Electronic City Phase II, Hosur Road, Bangalore - 560100, India. Bangalore KARNATAKA
8066332823
siddangouda.patil@syngeneintl.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sri Venkateshwara Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Rheumatoid arthritis
Intervention / Comparator Agent
Type
Name
Details
Intervention
DRL_Abatacept autoinjector
DRL_AB formulated for SC administration via an autoinjector, containing 125mg/mL, Single dose.
Comparator Agent
DRL_Abatacept prefilled syringe
DRL_AB formulated for SC administration via a PFS, containing 125mg/mL, Single dose.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
50.00 Year(s)
Gender
Male
Details
1. Healthy male volunteers aged 18 to 50 years, both inclusive, at the time of signing informed consent form.
2. Ability and amenability to provide written informed consent to participate in the study and adhere to study requirements.
3. Body mass index in the range 18.5 to 30.0 kg per square meter both inclusive and body weight of 60.0 to 100.0 kg, both inclusive.
4. General good health as determined by a qualified physician based on a comprehensive medical history, physical examination, vital signs, clinical laboratory tests like hematology, biochemistry, and urinalysis, and 12 lead electrocardiogram during screening.
5. Vital signs, physical examination, clinical laboratory tests, and 12 lead ECG results within normal range, or if outside the normal range, then assessed as clinically non significant by the investigator.
6. Willingness to use or with female partners willing to use at least one highly effective method of contraception as described below upto at least 3 months from the time of study intervention administration. Note, Highly effective birth control measures per Clinical Trials Facilitation and Coordination Group guidelines 2024 include the following
For a male participant
a. Permanently sterile by bilateral orchidectomy
b. Vasectomy
c. Maintaining sexual abstinence.
For the female partner of a male participant
a. Combined hormonal contraception associated with inhibition of ovulation oral, intravaginal, injectable, and transdermal
b. Progestogen only hormonal contraception associated with inhibition of ovulation oral, injectable, and implantable
c. Intrauterine device
d. Intrauterine hormone releasing system
e. Bilateral tubal occlusion
Sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Note The reliability of sexual abstinence needs to be evaluated as per investigator’s judgement in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. It should be considered as true abstinence only, and not periodic abstinence.
7. Willingness to abide by study restrictions for the entire study duration.
ExclusionCriteria
Details
1.Positive or 2 successive indeterminate test results for Quantiferon TB Gold test.
2. Positive results for syphilis, hepatitis B like HBsAg, HBsAb, HBcAb, hepatitis C, or human immunodeficiency virus 1 or 2.
3. Any prior exposure to abatacept or any other agent directly acting on CTLA4 or the CD28 CD80 co stimulation pathway including investigational products.
4. Vaccination with live vaccines within 3 months prior to screening or intention to receive live vaccines during the trial or up to 3 months after the administration of the study intervention. Participants who have been administered non live vaccines at least more than a week prior to study intervention administration may be included.
5. History of immunodeficiency or other clinically significant immunological disorders, autoimmune disorders, or ongoing or frequent per recurring infections defined as more than 3 infections per year requiring treatment, participants with prior herpes zoster infection not fully healed, including the post herpetic neuralgia period if present within one year prior to randomization, or participants with history of systemic fungal infection within the 6 months prior to screening.
6. Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins or any excipients like dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, L histidine, sodium chloride, poloxamer and sucrose of the study interventions.
7. History and or current manifestations of clinically significant, in the opinion of the investigator, atopic allergy, e.g., asthma including childhood asthma currently showing clinical manifestations, urticaria, angioedema, eczematous dermatitis, hypersensitivity, or allergic reactions or any history or presence of vasculitis or psoriasis.
8. Skin not suitable for dosing or post dosing evaluations on the upper arm for any reasons including presence of tattoos, skin pigmentation disorders, scarring etc., which may obscure the injection site.
9. Participation in blood donation or in any study requiring repeated blood sampling, hemorrhage requiring treatment, any transfusion in the past 3 months, or plasma donation within the 14 days prior to screening.
10. Systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg when measured in the sitting position after 5 minutes rest, or current use of antihypertensive drugs. Participants may be enrolled if blood pressure measurement is repeated up to 2 times on same or different days and if the mean of the measurements is within the above limits.
11. History of relevant orthostatic hypotension, fainting spells, or blackouts as well as history of difficulties with blood sampling that may potentially interfere with the study objectives and be deemed in the opinion of the investigator to pose clinical risk to the participants.
12. QTc Fridericia correction longer than 450 milliseconds or other clinically relevant ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf Parkinson White syndrome, or presence of a cardiac pacemaker as found relevant clinically by the investigator.
13. History or presence of any clinically relevant nervous system disease including, but not restricted to stroke, transient ischemic attack, or seizures other than febrile seizures before the age of 5 years.
14. History of and or current gastrointestinal, renal, endocrine, pulmonary, hepatic, cardiovascular, including history of or presence of angina, exertional dyspnea, orthopnea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment, hematological including pancytopenia, aplastic anemia or blood dyscrasia and coagulopathies, or an international normalized ratio more than 1.5, or metabolic disorders including known diabetes mellitus considered significant by the investigator. This criterion includes any disorder or condition that in the investigator’s opinion may interfere with the safety of the participant, the study evaluations, or the participant’s compliance to the study procedures and limitations.
15. Impaired hepatic function alanine transaminase or aspartate transaminase level more than 1.5× times upper limit of normal and or serum bilirubin 1.5× ULN at screening. A single repeat test on a different day is allowed. Participants with documented evidence of presence of Gilbert’s disease may be included if total bilirubin is 80 percent of the total bilirubin as per laboratory test.
16. Presence of any active infection assessed by the investigator even if minor and ongoing at the time of screening or on check in day or presence of any non healed wound or bone fracture of a clinically relevant size in the investigator’s opinion.
17. Participation in an interventional or phase 1 study in the last 3 months before enrollment, participation in more than 3 studies on experimental drug products in the past 12 months, intake of an investigational drug in a clinical trial setting within 3 months or 5 half lives, whichever is longer prior to intake of study drug in this trial, planned intake of an investigational drug with follow up visit scheduled during the course of this trial, or intake for any reason in the last 6 months of some specific long body residence drugs such as any immunoglobulin or antibody.
18. History of any cancer, including carcinoma in situ, lymphoma, or leukemia.
19. Major surgery within the past 6 months or any surgery including dental interventions within 3 months before study enrollment.
20. Intake of any medication including herbal products, vaccines, or immunomodulators within 3 weeks prior to study intervention administration other than nonsteroidal anti inflammatory drugs. If any other drugs have been used, there should not be any evidence of potential drug drug interaction with abatacept.
21. Current smokers or those who have given up smoking including use of alternative tobacco products such as chewing tobacco and vaping less than 3 months prior to screening, or participants with positive urine cotinine test at screening or check in.
22. Positive alcohol breath test or positive urine test for drugs of abuse including benzodiazepines, amphetamines, barbiturates, cocaine, methadone, phencyclidine, 3,4 methylenedioxymethamphetamine, tetrahydrocannabinol, and opiates, at screening or at check in.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Pharmacokinetic parameters: AUC0-t, Cmax, and AUC0-infinity
• Pharmacokinetic parameters: Tmax, lambda z, t1/2, Vz/f, CL/f, and percent AUCextrap
• Safety: Incidence of AEs, SAEs, and AESIs
• Samples for PK analysis will be obtained throughout the study (from pre-dose till Day 85).
• Safety- Baseline till Day 85/EOS
Target Sample Size
Total Sample Size="160" Sample Size from India="160" Final Enrollment numbers achieved (Total)= "160" Final Enrollment numbers achieved (India)="160"
Phase of Trial
Phase 1
Date of First Enrollment (India)
15/08/2025
Date of Study Completion (India)
11/10/2025
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
This is a Phase 1
comparative study conducted by Dr. Reddy’s Laboratories Ltd in male volunteers with
DRL_AB Auto-injector and Pre-filled Syringe.
Dr.Reddy’s
Abatacept (company product code: DRL_AB) is being developed as a biosimilar to
the US licensed Reference Abatacept (Orencia®) and EU approved Reference
(Orencia®). This study is part of global development program.
Normal healthy volunteers (NHV) are the
population of choice (unless precluded for safety reasons) to establish PK
similarity. The current study will be performed only in male subjects to avert gender-related
variability. The 125 mg SC single dose is known to be safe for administration
to NHV as it has been tested with appropriate safety and tolerability in prior
studies