Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 8, 2022

Primary Completion Date

June 25, 2024

Study Completion Date

January 9, 2025

Conditions
IPFFibrosis
Interventions
DRUG

RXC007

RXC007 will be administered in the form of oral capsules at 3 potential dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and the Expansion cohort will receive RXC007. The Dosage regimen is BID or QD.

DRUG

Placebo

The placebo will be administered in the form of oral capsules at each dose level to 4 of the 16 participants within cohorts 1, 2 and the Expansion cohort. The Dosage regimen is BID or QD

Trial Locations (31)

1090

Medical University of Vienna, Vienna

3000

E PNE UZ Leuven, Leuven

4000

CHU De Liège, Liège

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

20123

Ospedale S. Giuseppe Milano, Milan

28046

Hospital Universitario La Paz, Madrid

33011

Hospital Universitario Central de Asturias, Oviedo

37126

Azienda Ospedaliera Universitaria Integrata Verona, Verona

39008

Hospital Universitario Marqués de Valdecilla, Santander

41124

Azienda Ospedaliera Universitaria of Modena, Modena

60126

"Azienda Ospedaliero-Universitaria Ospedali-Riuniti di Ancona", Ancona

71122

Colonello D'avanzo Hospital, Foggia

73100

PO Vito Fazzi, Lecce

95123

Azienda Ospedaliero Universitaria Policlinico ''G.Rodolico-San Marco'', Catania

140 59

Pneumologicka klinika 1.LF UK a, Prague

00168

Fondazione Policlinico Universitario A. Gemelli, Roma

01-138

University Clinical Centre in Gdansk, Gdansk

Institute of Tuberculosis and Lung Diseases in Warsaw, Warsaw

Unknown

Barlicki University Hospital, Lodz

University Hospital of Geneve, Geneva

08006

Policlinica Barcelona, Barcelona

08036

Hospital Universitario Clínic de Barcelona, Barcelona

08907

L'Hospital Universitari de Bellvitge, Barcelona

BT97AB

Belfast City Hospital, Belfast

B15 2GW

Queen Elizabeth Hospital, Birmingham

CB2 0AY

Royal Papworth Hospital NHSFT, Cambridge

EH16 4SA

Royal Infirmary of Edinburgh, Edinburgh

SE1 9RT

Guy's Hospital, London

SW3 6HP

Royal Brompton Hospital, London

BT476SB

Altnagelvin Area Hospital, Londonderry

OX7 3LE

Churchill Hospital, Oxford University Hospitals NHS Trust, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Simbec-Orion Group

INDUSTRY

lead

Redx Pharma Ltd

INDUSTRY