NCT07744828
A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants
Not Yet Recruiting · Phase 1 · Dr. Reddy's Laboratories Limited · registry updated 2026-08-04
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- 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.
Exclusion
- Positive or 2 successive indeterminate test results for Quantiferon-tuberculosis (TB) Gold test.
- Positive results for syphilis, hepatitis B (HBsAg, HBsAb, HBcAb), hepatitis C, or human immunodeficiency virus (HIV)-1 or 2.
- Any prior exposure to abatacept or any other agent directly acting on CTLA4 or the CD28-CD80 co-stimulation pathway \[e.g., pembrolizumab, ipilimumab, nivolumab, and atezolizumab\] including investigational products.
- 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.
- History of immunodeficiency or other clinically significant immunological disorders, autoimmune disorders, or ongoing or frequent/recurring infections defined as \>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.
- 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) of the study interventions.