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LOXL2 and TGFbeta1 Signaling Inhibitor
Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.
Phase < 1
Waitlist Available
Led By Hal A Chapman, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 4, 12 hours post dose
Awards & highlights
No Placebo-Only Group
Summary
This is a two part study. In the first part, the pharmacokinetic profile of Epigallocatechin-3-gallate (EGCG) in normal human volunteers given a single oral dose will be determined to set the dose for the second part of the study. In the second part of this study, lung biopsy fragments and urine samples from patients with interstitial lung disease treated with EGCG will be evaluated in biochemical assays and compared to samples from untreated control patients.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 4, 12 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 4, 12 hours post dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of Serum Biomarker COMP Before and After EGCG Treatment in ILD Patients
Change of Serum Biomarker Periostin Before and After EGCG Treatment in ILD Patients
Difference of Biomarker Collagen I Between EGCG-treated and Non-treated Patient Groups
+3 moreSecondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of EGCG
Maximum plasma concentration of EGCG
Plasma exposure of EGCG
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: EGCG treatment in ILD patientsExperimental Treatment1 Intervention
Patients: 600 mg EGCG capsules once daily by mouth for two weeks
Group II: EGCG PK in healthy volunteers 750 mgExperimental Treatment1 Intervention
Healthy volunteers: 750 mg Epigallocatechin-3-gallate (EGCG) capsules administered once daily by mouth
Group III: EGCG PK in healthy volunteers 600 mgExperimental Treatment1 Intervention
Healthy volunteers: 600 mg Epigallocatechin-3-gallate (EGCG) capsules administered once daily by mouth
Group IV: EGCG PK in healthy volunteers 450 mgExperimental Treatment1 Intervention
Healthy volunteers: 450 mg Epigallocatechin-3-gallate (EGCG) capsules administered once daily by mouth
Group V: No treatment control in ILD patientsActive Control1 Intervention
Patients: not treated with EGCG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epigallocatechin-3-gallate (EGCG)
2017
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,901,694 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
1,262 Patients Enrolled for Idiopathic Pulmonary Fibrosis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,942 Previous Clinical Trials
47,793,203 Total Patients Enrolled
22 Trials studying Idiopathic Pulmonary Fibrosis
4,566 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Hal ChapmanLead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
72 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Hal A Chapman, MDPrincipal InvestigatorUC San Francisco