ClinicalTrials.gg
Not yet recruitingNCT07744828Updated Aug 4, 2026

A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants

A Phase 1 interventional study of DRL_AB in Healthy Volunteers, sponsored by Dr. Reddy's Laboratories Limited. Not yet recruiting at 3 sites in New Zealand. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Arthritis, Rheumatoid
  • Arthritis
  • Joint Diseases
  • Rheumatic Diseases
  • Psoriatic Arthritis
  • Polyarticular Juvenile Idiopathic Arthritis
  • Acute Graft Versus Host Disease
03

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's planned enrollment of 160 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male volunteers aged 18 to 50 years (both inclusive) at the time of signing form.
  2. Ability and amenability to provide written informed consent to participate in the study and adhere to study requirements.
  3. 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).
  4. 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 (ECG) 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 (unless the value constitutes an explicit exclusion criterion).
  6. Willingness to use or with female partners (women of [WOCBP]) willing to use at least one highly effective method of 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
    • 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 (such as calendar, symptothermal, post-ovulation methods)].
  7. Willingness to abide by study restrictions for the entire study duration.

Exclusion criteria

Exclusion Criteria:

  1. Positive or 2 successive indeterminate test results for Quantiferon-tuberculosis (TB) Gold test.
  2. Positive results for syphilis, (HBsAg, HBsAb, HBcAb), , or (HIV)-1 or 2.
  3. 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 products.
  4. Vaccination with 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 immunological disorders, 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.
  6. Allergy or to any recombinant human or humanized antibodies, other therapeutic proteins or any (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 >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.
  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. (Fridericia correction) longer than 450 milliseconds or other clinically relevant 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, , 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 (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.
  15. Impaired hepatic function ( [ALT] or aspartate transaminase [AST] level >1.5× times [ULN] and/or serum total 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.
  16. Participants with >= 6.5%, indicative of diabetes mellitus
  17. 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.
  18. 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.
  19. History of any cancer, including carcinoma in situ, lymphoma, or leukemia.
  20. Major surgery within the past 6 months or any surgery including dental interventions within 3 months before study enrollment.
  21. Intake of any medication including herbal products, vaccines, or immunomodulators within 3 weeks prior to study intervention administration other than nonsteroidal anti-inflammatory drugs (NSAIDs). If any other drugs have been used, there should not be any evidence of potential drug-drug interaction with abatacept.
  22. Current smokers or those who have given up smoking including use of alternative tobacco products such as chewing tobacco and vaping \<=2 weeks prior to screening, or participants with positive urine cotinine test at screening or check-in.
  23. 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.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    DRL_AB 125 mg via AI

    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

  • Active comparator
    DRL_AB 125 mg via PFS

    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

  • BiologicalDRL_AB

    DRL\_AB administered as a SC injection.

06

What researchers measure

Primary outcomes

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

    Time frame: 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

  2. Maximum Measured Serum Concentration (Cmax) in DRL_AB

    Time frame: 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

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

    Time frame: 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

  1. Time of the Maximum Measured Serum Concentration (Tmax) of DRL_AB

    Time frame: 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

  2. Apparent Terminal Decline Rate Constant (λz) of DRL_AB

    Time frame: 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

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

    Time frame: 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

  4. Apparent Volume of Distribution (Vz/f) of DRL_AB

    Time frame: 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

  5. Apparent Body Clearance (CL/f) of DRL_AB

    Time frame: 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

  6. Area Under the Curve Extrapolated as a Percentage of the Total (%AUCextrap) of DRL_AB

    Time frame: 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

  7. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

    The AESIs to be monitored in this study are anaphylactic reactions, hypersensitivity reactions, infections requiring intravenous antibiotic therapy, and injection site reactions.

    Time frame: From start of study drug administration to end of study (EOS) (Up to Day 71)

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: Undecided — The sponsor will be responsible for knowledge dissemination such as the study design or the study outcomes to relevant target audience including publications as laid down in its publications policy.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.

Of 128 industry-sponsored phase 1 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 4 months is below that.

Counting every sponsor, half of 148 studies reached it within 16 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 4, 2026
StartEst.
Aug 19, 2026
Primary completionEst.
Dec 29, 2026
CompletionEst.
Dec 29, 2026
Last update
Aug 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07744828
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Aug 19, 2026 (estimated)
Primary completion
Dec 29, 2026 (estimated)
Completion
Dec 29, 2026 (estimated)
Last update
Aug 4, 2026

Study contacts

Naveen Reddy
Contact
naveenreddy@drreddys.com
+91 8008558076

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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