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A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects

NCT03093714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-04-12

No results posted yet for this study

Summary

This is a multicenter, randomized, placebo-controlled, dose-escalation study. Enrollment is planned to occur at approximately 14 global sites. Approximately 24 subjects with CF.

Conditions

Interventions

DRUG

FDL169

CFTR corrector

DRUG

Placebo

Placebo for FDL169

Sponsors & Collaborators

  • Flatley Discovery Lab LLC

    lead OTHER

Principal Investigators

  • Claudia Ordonez, MD · Flatley Discovery Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2018-04-03
Completion
2018-04-03

Countries

  • Australia
  • Czechia
  • Germany
  • United Kingdom

Study Locations

More Related Trials

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 NCT03093714 on ClinicalTrials.gov