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Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route

NCT06126042 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-11-13

No results posted yet for this study

Summary

This is a randomised, double-blind, single dose, parallel groups study to compare the PK, immunogenicity, and safety of 3 abatacept products (DRL\_AB, RP and RMP) in male NHV.

Conditions

Interventions

DRUG

Test Product

DRL\_AB, Pre Filled Syringe; Solution for injection

DRUG

Reference product

USA licenced ORENCIA®, Pre Filled Syringe; Solution for injection

DRUG

Reference Medicinal Product

EU approved ORENCIA®, Pre Filled Syringe; Solution for injection

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Naveen Reddy, MD · Dr. Reddy's Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2024-04-30
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126042 on ClinicalTrials.gov