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COMPLETED
NCT04007198
PHASE1

A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma

Sponsor: Biocon Limited

View on ClinicalTrials.gov

Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.

Official title: A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Moderate-to-Severe Uncontrolled Asthma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2019-06-20

Completion Date

2021-10-12

Last Updated

2026-06-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

EQ001

Itolizumab \[Bmab 600\]

DRUG

EQ001 Placebo

EQ001 Placebo

Locations (13)

Flinders Medical Centre

Adelaide, Australia

Box Hill Hospital

Box Hill, Australia

Monash Medical Centre

Clayton, Australia

Paratus Clinical Research Central Coast

Kanwal, Australia

Respiratory Clinical Trials

Kent Town, Australia

TrialsWest

Murdoch, Australia

Melbourne Health

Parkville, Australia

Paratus Clinical Research Western Sydney

Sydney, Australia

The Queen Elizabeth Hospital

Woodville, Australia

Respiratory Research, Greenland Clinical Centre

Auckland, New Zealand

Dunedin Hospital

Dunedin, New Zealand

The New Zealand Respiratory & Sleep Institute

Greenlane, New Zealand

Medical Research Institute of New Zealand

Wellington, New Zealand