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

NCT05570058 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-08-23

No results posted yet for this study

Summary

The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12 weeks (84 days), alone and in combination with nintedanib or pirfenidone.

Conditions

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

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY

  • Redx Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Philip Molyneaux, MD · Royal Brompton & Harefield NHS Foundation Trust

  • Toby Maher, MD · University of Southern California, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2024-06-25
Completion
2025-01-09
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Czechia
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT05570058 on ClinicalTrials.gov