None listed
Conditions
Interventions
Intervention1: Dr Reddys Abatacept (DRL_AB): Subjects will receive 1 dose of either treatment DRL_AB or RP or RMP as per the randomisation schedule. will be administered as a single SC dose of 125 mg
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be eligible to be included in the study only if all of the following criteria apply: 1. Age 18 to 50 years (both inclusive) at the time of signing informed consent. 2. Male sex. 3. In general, good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory hematology, clinical chemistry, urinalysis and 12-lead ECG before randomization. 4. Body mass index in the range of 18.5-30.0 kg per meter square (both inclusive) and body weight in the range of 60.0-100.0 kg (both inclusive). 5. Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG, and thyroid function) within the normal range or if outside the normal range, then assessed as clinically non-significant by the investigator (unless the value constitutes an explicit exclusion criterion). 6. Willingness of participants or their female partners (if they are women of childbearing potential (WOCBP)) to use at least 1 highly effective method of contraception as described below and to refrain from sperm donation from the time of study drug administration until 3 months after dosing. Highly effective birth control measures as per CTCG (Clinical Trials Coordination Group) guidelines 2024 17 include the following: For a participant: • Permanently sterile by bilateral orchidectomy • Sexual abstinence For the female partner of a male participant: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral, intravaginal, and transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, implantable • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence 7. Voluntary agreement to participate in the study by providing written informed consent. 8. Willingness to stay on study restrictions for up to 16 weeks (from the time of screening until 3 months after dosing) and to abide by the study procedures during the follow up if and as applicable.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if any of the following criteria apply: 1. Positive test result for Quantiferon-TB Gold test, syphilis, hepatitis B, hepatitis C, or HIV-1 or 2. 2. 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 drug. Non-live vaccines should be administered at least a week before the study drug administration to avoid interference with vaccine immunity development (and to get clean readout of test drug related immunogenicity development). 3. Any prior exposure to abatacept or to any other agent directly acting on CTLA-4 or the CD28-CD80 co-stimulation pathway (e.g. pembrolizumab, ipilimumab, nivolumab and atezolizumab) including investigational products (to prevent interaction and resultant safety concerns). 4. History of immunodeficiency or other clinically significant immunological disorders, or auto-immune disorders. 5. History of systemic fungal infection for the last 6 months. 6. Presence of ongoing infection or history of frequent/recurring infection (defined as more than 3 infections requiring treatment per year) or prior herpes zoster infection not fully healed (including the post-herpetic neuralgia period if occurring) within 1 year prior to randomization. 7. Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins or any excipients (dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, L-histidine, sodium chloride, poloxamer and sucrose) in the study formulations. 8. History and/or current presence of clinically significant (in the opinion of the investigator) atopic allergy (e.g., asthma including childhood asthma, urticaria, angioedema, eczematous dermatitis), hypersensitivity or allergic reactions or any history or presence of vasculitis or psoriasis. 9. Non-suitable skin at planned injection site for dosing or changes in the injection site interfering with its evaluation, including presence of tattoos, pigmentation, or lesions obscuring the injection site. 10. Blood donation, participation in any study requiring repeated blood sampling, hemorrhage requiring treatment or any transfusion in the past 3 months, or plasma donation within the 14 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters AUC0-infinite and Cmax.Timepoint: A total of 27 blood samples for PK analysis will be obtained within 1 hour prior to the administration of study drug, and at 1 h, 4 h, 12 h, 24 h (Day 2), 36 h (Day 2), 48 h (Day 3), 60 h (Day 3), 72 h (Day 4), 84 h (Day 4), 96 h (Day 5), 108 h (Day 5), 120 h (Day 6), 132 h (Day 6), 144 h (Day 7), 156 h (Day 7), 168 h (Day 8), 216 h (Day 10), 336 h (Day 15), 504 h (Day 22), 672 h (Day 29), 840 h (Day 36), 1008 h (Day 43), 1176 h (Day 50), 1344 h (Day 57), 1680 h (Day 71) and 2016 h (Day 85 or EoS). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Pharmacokinetic parameters AUC0-t, tmax, lamda z, t1/2, CL/f, and Vz/f. â?¢ Incidence of overall TEAEs, IRRs, ISRs, and abnormal and clinically significant results for vital signs, physical examination, ECG, and clinical laboratory parameters from baseline to EoS. â?¢ Proportion of participants with confirmed positive status for abatacept and CTLA-4 ADAs from baseline through scheduled timepoints till EoS. â?¢ Proportion of ADA-positive participants with NAbs from baseline through scheduled timepoints till EoS. â?¢ ADA titer in ADA-positive participants from baseline through scheduled timepoints till EoS.Timepoint: A total of 5 blood samples for immunogenicity assessment will be collected at pre-dose (-1 h), and on Days 15 (336 h), 29 (672 h), 43 (1008 h) and at the EoS (Day 85 [2016 h]) visit post-dose for all participants. | — |
Countries
India
Contacts
Public ContactNaveen Reddy
Dr. Reddyâ??s Laboratories Ltd.
Outcome results
None listed