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NOT YET RECRUITING
NCT07744828
PHASE1

A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants

Sponsor: Dr. Reddy's Laboratories Limited

View on ClinicalTrials.gov

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.

Official title: A Single-dose, Randomized, Open-label, Parallel-arm, Comparative Pharmacokinetic and Safety Study of Proposed Abatacept Biosimilar DRL_AB Administered by the Subcutaneous Route Via Autoinjector or Prefilled Syringe to Normal, Healthy, Male Participants

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-08-19

Completion Date

2026-12-29

Last Updated

2026-08-04

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

DRL_AB

DRL\_AB administered as a SC injection.

Locations (3)

Momentum Clinical Research

Auckland, New Zealand

New Zealand Clinical Research

Auckland, New Zealand

New Zealand Clinical Research

Christchurch, New Zealand