Not Yet RecruitingPhase 1

A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants

New Zealand160 participantsStarted 2026-08-19

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

. 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.
. Willingness to abide by study restrictions for the entire study duration.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 1 pharmacokinetics study in healthy volunteers — meaning it's focused on how the body absorbs and processes the drug DRL_AB rather than treating a disease — so what would be the potential benefit for me as a participant, and is there any direct health benefit at all?
2Since this trial is not yet recruiting, how long might it realistically be before it opens, and would waiting to potentially join affect any current health decisions or timelines I should be thinking about?
3The study is enrolling healthy male participants only — given that restriction, does my doctor think I would even meet the eligibility criteria, and are there any health conditions or medications I have that might disqualify me?
4Phase 1 trials are primarily designed to study drug behavior in the body, which means the safety profile of DRL_AB in humans is still being established — what known or potential risks should I be aware of before considering whether this is worth discussing further?
5Since this study measures how DRL_AB moves through the body over time using repeated blood draws, what kind of time commitment and procedures would likely be involved, and how might that fit with my day-to-day life?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT07744828

SponsorDr. Reddy's Laboratories Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-29

Contact for this trial

Naveen Reddy

+91 8008558076 naveenreddy@drreddys.com

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

. 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.
. Willingness to abide by study restrictions for the entire study duration.
. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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