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DRL_AB

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Aug 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

DRL_AB · 1 trial · 1 indication

Phase 1 1
NCT07744828A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male ParticipantsHealthy Volunteers
NOT YET_RECRUITING160 Analytics
PHASE1NOT YET_RECRUITING
A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
DRL_AB 125 mg via AIEXPERIMENTALParticipants 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.
DRL_AB 125 mg via PFSACTIVE_COMPARATORParticipants will receive a single SC dose of DRL\_AB, 125 mg in a PFS on Day 1 of the treatment period of 70 days.

Interventions

NameTypeDescription
DRL_ABBIOLOGICALDRL\_AB administered as a SC injection.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Healthy male volunteers aged 18 to 50 years (both inclusive) at the time of signing informed consent form. 2. Ability and amenability to provide written informed consent to participate in the study and adhere to study requirements. 3. Body mass index in the range 18.5-30.0 ki...

Countries:New Zealand
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Recent Changes (Last 90 Days)

LOWAug 4, 2026NCT07744828NEW_TRIAL: changed
LOWAug 4, 2026NCT07744828NEW_TRIAL: changed

Frequently asked questions about DRL_AB

What is DRL_AB?

DRL_AB is an investigational monoclonal antibody being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in a clinical trial to evaluate its pharmacokinetics in healthy male participants.

What does DRL_AB target?

DRL_AB is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied in healthy volunteers to evaluate its pharmacokinetics, which includes how the body absorbs, distributes, metabolizes, and excretes the drug.

Who makes DRL_AB?

DRL_AB is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting a Phase 1 clinical trial to evaluate the drug's pharmacokinetics in healthy male participants.

What phase is DRL_AB in?

DRL_AB is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to evaluate the pharmacokinetics of DRL_AB in healthy male participants.

What clinical trials is DRL_AB in?

DRL_AB is being studied in a Phase 1 clinical trial with the identifier NCT07744828. The trial is titled 'A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants' and is planned to enroll 160 healthy male participants in New Zealand. The trial is not yet recruiting.

Is DRL_AB the same as any other drug?

No alternative names for DRL_AB have been disclosed. The drug is being developed under the code name DRL_AB by Dr. Reddy's Laboratories Ltd and is currently in Phase 1 clinical trials for healthy volunteers.