The purpose of this study is to assess the PK comparability and compare safety and tolerability of DRL_AB administered via an auto injector (AI) or prefilled syringe (PFS) in healthy male participants.
Inclusion Criteria:
Healthy male volunteers aged 18 to 50 years (both inclusive) at the time of signing informed consent form.
Ability and amenability to provide written informed consent to participate in the study and adhere to study requirements.
Body mass index in the range 18.5-30.0 kilogram per meter square (kg/m^2) (both inclusive) and body weight of 60.0-100.0 kilogram (kg) (both inclusive).
General good health as determined by a qualified physician based on a comprehensive medical history, physical examination, vital signs, clinical laboratory tests (hematology, biochemistry, and urinalysis), and 12-lead electrocardiogram (ECG) during screening.
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 (unless the value constitutes an explicit exclusion criterion).
Willingness to use or with female partners (women of childbearing potential [WOCBP]) willing to use at least one highly effective method of contraception as described below up to at least 3 months from the time of study intervention administration.
Note: Highly effective birth control measures per Clinical Trials Facilitation and Coordination Group (CTCG) guidelines 202414 include the following:
For a male participant:
For the female partner of a male participant:
Willingness to abide by study restrictions for the entire study duration.
Exclusion Criteria:
naveenreddy@drreddys.com
Participants will receive a single subcutaneous (SC) dose of DRL\_AB, 125 milligrams (mg) in an AI on Day 1 of the treatment period of 70 days.
Participants will receive a single SC dose of DRL\_AB, 125 mg in a PFS on Day 1 of the treatment period of 70 days.
Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route
Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes