A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants

NCT07744828 | Not Yet Recruiting Phase 1

• 1 other identifier: AB-01-010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Rheumatic Diseases; Psoriatic Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (3)

• Area Under the Serum Concentration Versus Time Curve From Time 0 Extrapolated to Time t (AUC0-t) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

• Maximum Measured Serum Concentration (Cmax) in DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

• Area Under the Serum Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC0-∞) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

Secondary Outcomes (7)

• Time of the Maximum Measured Serum Concentration (Tmax) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

• Apparent Terminal Decline Rate Constant (λz) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

• Terminal Elimination Half-life (t1/2) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

• Apparent Volume of Distribution (Vz/f) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

• Apparent Body Clearance (CL/f) of DRL_AB

  Pre-dose on Day 1. Post-dose at 1, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 216, 336, 504, 672, 840, 1008, 1176, 1344 and 1680 hours

Study Arms (2)

DRL_AB 125 mg via AI

EXPERIMENTAL

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.

Biological: DRL_AB

DRL_AB 125 mg via PFS

ACTIVE COMPARATOR

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.

Biological: DRL_AB

Interventions

DRL_AB BIOLOGICAL

DRL\_AB administered as a SC injection.

DRL_AB 125 mg via AI; DRL_AB 125 mg via PFS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The current study will be performed only in male participants to avert gender-related variability.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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:
• Permanently sterile by bilateral orchidectomy
• Vasectomy
• Maintaining sexual abstinence\*.
• For the female partner of a male participant:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral, intravaginal, injectable, and transdermal.
• Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, and implantable.
• Intrauterine device
• Intrauterine hormone-releasing system

You may not qualify if:

• 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.
• 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.
• 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).
• 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.
• Systolic blood pressure \>140 millimeter of mercury (mm Hg) or diastolic blood pressure \>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.
• 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.
• 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.
• 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.
• 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 (INR) \>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.
• Impaired hepatic function (alanine transaminase \[ALT\] or aspartate transaminase \[AST\] level \>1.5× times upper limit of normal \[ULN\] and/or serum total 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% of the total bilirubin as per laboratory test.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (3)

Momentum Clinical Research

Auckland, New Zealand

Location

New Zealand Clinical Research

Auckland, New Zealand

Location

New Zealand Clinical Research

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Rheumatic Diseases; Arthritis, Psoriatic; Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Central Study Contacts

Naveen Reddy

CONTACT

+91 8008558076; naveenreddy@drreddys.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 19, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

NZ (3)